sdc100 wrote:No, they're not because they've never been submitted to the FDA for approval. If your claim is correct, what is the FDA approval number?

If the company had not made any medical claims, they don't need to go through FDA approval. But if claims are made of being a TENS or EMS device, which is clear from their description, the company has to prove safety as well as efficacy.

Well, the company Prospera is FDA registered. From the FDA web site:


Establishment:
PROSPERA CORPORATION
405 Boulder Ct Suite 500
Pleasanton, CA 94566
Registration Number: 3009049803
Status: Active
Initial Distributor/Importer: Yes
*Note Firm May Have Additional Establishment Types.
Please Review Listings For Further Information.
Date Of Registration Status: 2012

Owner/Operator:
Prospera Corporation
405 Boulder Court
Suite 500
Pleasanton, CA 94566
Owner/Operator Number: 10037598

Official Correspondent:
Jane Ding
405 Boulder Court
Suite 500
Pleasanton, CA 94566
Phone: 925-225-0888

Plus the FDA disclaimer: "Note: Registration of a device establishment, assignment of a registration number, or listing of a medical device does not in any way denote approval of the establishment or its products by FDA."

Draw your own conclusions.

wouldyoulikesometinychicken wrote:Please google "argument from antiquity". The use of blood-letting and leeches is also centuries old. Doesn't mean it does jack.

Doctors still use leeches to treat venous congestion.

I take it this is not compatible with my jet spa?

If you live in a state where Woot collects sales tax (WA, TX or NY), consider buying 2 and then using the coupon code, "TAXSUCKS." You'll then get $5 back and actually end up spending less than someone who doesn't pay sales tax. That's because sales tax on 2 units ends up being less than $5.

I was told by a doctor that you need a prescription to buy one of these. Looks like I beat the system

sdc100 wrote:No, they're not because they've never been submitted to the FDA for approval. If your claim is correct, what is the FDA approval number?

If the company had not made any medical claims, they don't need to go through FDA approval. But if claims are made of being a TENS or EMS device, which is clear from their description, the company has to prove safety as well as efficacy.

Every website selling them including woot mention that it is FDA registered and approved. Please, in the future actually look into things before blowing smoke out your rear.

sdc100 wrote:Well, my mother and several patients would disagree with you. Pads can not adhere for many reasons, ranging from body hair to sweat to movement. My moms like to use her unit while cooking and doing chores. Without the belt, you'd have wires dangling. A good belt not only organizes the wires, but also has a pocket to hold the main unit. Everything is self-contained under your shirt. As for placing it in your pocket, I wouldn't recommend it, espeially the back pocket. At least one patient had accidentally increased the intensity to an very comfortable level. It's a especially high risk with this device, which uses a wheel. Purely digital controls, like that on the Sharper Image, often have an auto-lockout, which prevents the buttons from functioning. You can't do that with this dial.

And no, using worn out pads doesn't cause shocks. The whole point is to feel shocks, so the conductive gel actually helps to transmit shocks. As for Sharper Image, your broad statement is it wrong. Very few items are manufactured by Sharper Image, especially today. They usually just stamped their name on thigns by other reputable manufactuters, often Casio, Panasonic, Sony, etc.

It seems like you have very little experience actually using one of these devices. Yes, using wornout pads is exactly how shocks happen. It decreases the surface area for the current to pass, and, therefor, a larger current is passed in a small area which causes a shock. Avoiding shocks is exactly why the doctor uses the gel. To increase the surface area that is actually transmitting curent. As for the belts vs pads, you are supposed to use them on clean dry skin either way. Just cause your mom uses it improperly does not mean it is a better way. If you too stupid to be able to put a device in your pocket without hitting the numbers, then you probably shouldnt be treating your own pain anyways. Just because 1 user had a problem doesnt mean that it is a design flaw. Just means that there is 1 careless user. Its like saying you shouldnt use cruise control in your car cause you might accidentally bump it up to a higher speed and get in a wreck.
Yes sharper image went bankrupt cause hey mostly made plastic gimmicky crap that was rebranded with their name cause the original manufacturer didnt want to sell it.

bucsfanp7 wrote:I always question "western medicine"--which has been around only a few hundred years-- proponents when they deride "eastern medicine" because it has been around for literally thousands of years.

While true that there are charlatans and cons pushing homeopathic remedies, genuine eastern practitioners have been known to greatly relieve pain, discomfort and illnesses that western doctors only want to give you a pill for, which only treats the symptoms, not the problem.

I'll take eastern over western ANY time. Thank goodness that insurance companies are FINALLY recognizing the same facts..albeit v-e-r-y slowly.

It seems to me that Western medicine tends to shy away from things that must be practiced as techniques and things that treat symptoms. They especially hate things that the practicioners don't know why it works, even if it does work (I dunno about Chi, but if you apply firm pressure to the tissue between your thumb and forefinger, it hurts a bit, but then your hands feel golden for a while and you can continue writing essays).

If I can use this to remove the knots in my back (I've been using a "mouse massager"), the relief is fine regardless of how temporary the relief is.

Bird2112 wrote:Go see a podiatrist, get orthotic insoles and quit buying unsupportive shoes. It's the only way I got rid of Faciitis.

Tried all of that and hasn't helped, which is why I am asking if these have helped anyone with plantar fasciitis...

mjaz62 wrote:Does anyone know if this will work on charley-horse leg cramps? Thanks in advance!

As a sports massage therapist I found tens units did not help with a "charley-horse"leg cramp..which is most likely due to low potassium of magnesium. I personnally have treated myself with tonic water..which has quinine..check with you doctor..as does have risks. Tens units are wonderful for muscle spasm,strains and sprains and just general tightness. Use mine daily.

sdc100 wrote: In fact, there are two buttons to change the "speed of the pulse." That is the definition of frequency in a digital device.

This is not actually true. "speed of pulse" in a digital system is more correctly referred to as the pulse repetition frequency, these pulses are themselves carrier on/ off, also called duty cycle. In this case the carrier or tone frequency is 60hz, and the duty cycle is adjusted by the buttons you mention.

time2testit wrote:Tried all of that and hasn't helped, which is why I am asking if these have helped anyone with plantar fasciitis...

Yes..as a sports massage therapist..I have ssen excellant results with a tens unit for PF. The pads should be placed on rt and lf side of foot and 2 in archway..one inch apart. Duration varies..30 min..and up. Always consult your health care provider for duration.Very positive results in my practice.

sjriney wrote:If you too stupid to be able to put a device in your pocket without hitting the numbers, then you probably shouldnt be treating your own pain anyways.

Actually i own this item and i think it would be very hard to put this "device in your pocket without hitting the numbers". The analog dials are on both sides of this device and if i move at all i change the settings. Not sure how you or anyone could do it.

And i am not "stupid"

What size are the pads that come with this? Some here have said it is better to buy bigger pads. Most pads I see on Amazon are 2"x2" and some mention non-irritating while some mention cloth versions. Anyone used any of these? Are these any good (and a good size)?

http://www.amazon.com/gp/product/B006VKRVI2/ref=ox_sc_act_title_2?ie=UTF8&m=A8YXBQ7YB5YFQ

AND - is it recommended to use these with electrode gel? Someone here recommended this one but one review says you don't use these gels with the TENS pads?

http://www.amazon.com/gp/product/B006VKRVI2/ref=ox_sc_act_title_2?ie=UTF8&m=A8YXBQ7YB5YFQ

sjriney wrote:Every website selling them including woot mention that it is FDA registered and approved. Please, in the future actually look into things before blowing smoke out your rear.

Looks like some research was overlooked. The FDA only lists the company, not the device, in the FDA "Establishment Registration & Device Listing" database.

You can check here: http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfRL/rl.cfm

The FDA warns: "Registration of a device establishment, assignment of a registration number, or listing of a medical device does not in any way denote approval of the establishment or its products by FDA."

How long can you use the pads? Do they need replacing frequently?

There are many inexpensive electrodes for sale at Amazon.com. For example:

http://www.amazon.com/Santamedical-Electrodes-Square-Re-Usable-Non-Irritating/dp/B006VKRVI2/ref=sr_1_17?s=hpc&ie=UTF8&qid=1332792913&sr=1-17

1) It claims to be both TENS and EMS, yet there is no setting to choose between the two.

At not point in the description you linked does it claim to be an EMS.

2) It claims to be "Ideal for relieving sore muscles caused by exercise, muscle spasms, and carpal-tunnel syndrome." You don't relieve the pain of muscle spasms by causing more muscle spasms!

If it isn't a EMS, then it shouldn't stimulate muscles.

3) It claims "This FDA-approved device has been prescriped by doctors, chiropractors, and physical therapists." It is only FDA-approved in the sense that such devices are considered safe. My bet is that this specific devices was never submitted to the FDA, and they're unaware of the claims...And it has never been "prescribed" by doctors because this DOESN'T REQUIRE A PRESCRIPTION!

It doesn't claim to be anything other than FDA approved. There are no associated claims that are FDA approved, only that the device is approved. As far as the prescription, it is simply semantics regarding which definition of "prescribed" you choose to use. It never claims a medical script is required.

4) Instead, it makes claims based on the Western modalities of TENS and EMS. Yet 6 programs have no correlates in Western Medicine...IN those legitimate therapies, a set frequency is applied throughout the entire session, although intensity is often slowly increased to the maximum of tolerance.

TENS units typically include variation of frequencies and intensities to find the combination that provides the best pain relief. The alternative would be to provide only one frequency and intensity, and this simply isn't the case in their application.

RWoodward wrote:A not-so simple question for someone who might know:
I have stenosis in my lumbar spine.

Simple answer, and the best - talk to your doctor or physical therapist. They would know. No one here can give you advice on this, since they don't know your condition, your history or your other problems. It could do one of three things - 1) help you, 2) hurt you, or 3) do nothing for you. Give your doc or therapist a quick call, since this Woot is probably not going to sell out quickly.

Tiahaar wrote:"■In addition to your back and neck, it can be used on your shoulders, legs, arms, and feet"

you know very well where this thing will be used... :D

I was wondering if only 1 pad thingy could be used! ;)

sjriney wrote:Every website selling them including woot mention that it is FDA registered and approved. Please, in the future actually look into things before blowing smoke out your rear.

This device is FDA registered. It is not FDA approved. Registered simply means they've sent in an application to be put in the registration database.

I became a "Pulitzer Prize Candidate" by sending the Pulitzer committee an application. I didn't win, though....

Well, I got one. Woot, why don't you clarify if it really is a TENS unit or not?

kuma99 wrote:Are these new?... or refurbished?

Per the main header of this item, they are new.
"Prospera Electronic Pulse Massager $19.99 + $5 shipping
CONDITION: New"

Katonklin wrote:This "well-researched article does not come up on the computer. Is the link correct?

Acupuncture as an anesthetic has not been embraced by Westerners to a large degree for numerous reasons. There are legal, skill and knowledge of practitioners, beliefs of patients in the west and far more than can be identified at the moment, but to say that it is the placebo effect is naive and giving a very limited view of the subject and this view is also limited as well. If anyone is interested, in medical practices that have been used for thousands of years and are exceptionally foreign to westerners, please see the YouTube videos of Bill Moyers Healing and the Mind.

These quotes and videos do not cite peer-reviewed journals, yet have a compelling message as to possibilities for greater comfort and healing of patients that is quite different from Western methods. Sorry to be so long-winded. Namaste friends.

For those interested, and especially those who haven't read the past posts, the above is a rebuttal in part and has interspersed within it the original post and my own comments, which I did not know how to separate out so that the separation of each was obvious. I apologize for making a long post even more difficult to wade through by not knowing how to post differently.

talynn wrote:where did you get your pads

I ordered mine off from Amazon: http://www.amazon.com/gp/product/B001TZJYXE/ref=oh_o01_s00_i00_details

The pads are a bit larger than the ones that come with the unit. As mentioned by others, if you wash the area prior to applying the pads (make sure you dry the area as well), the pads will last a lot longer.

any problems with paypal? after i hit the button to purchase and sign in to paypal, it asks me for another credit card. paypal says it is not them and my acct is fine???

cliffpeterson wrote:This device is FDA registered. It is not FDA approved. Registered simply means they've sent in an application to be put in the registration database.

I became a "Pulitzer Prize Candidate" by sending the Pulitzer committee an application. I didn't win, though....

Where can I get a Pulitzer Prize application? I'm going to do the same thing. Maybe a Nobel prize also. ;]

Can someone please verify if this is a TENS or an EMS unit? Also, what size pads come with this unit?

I meant to post this earlier today but ran out of time before leaving for work.

Apparently, this is not a TENS unit, though it bears some similarity to them. It is a electronic muscle stimulator, or E-Stim unit, like those used in Chiropractors' and perhaps some physical therapists' offices.

Download the manual and you will not see any reference to it being a TENS unit. TENS units are regulated in the US by the FDA. I know, because I bought one from England and had it shipped to the US, only to be stopped at US Customs by the FDA. I had to prove I had a prescription for the unit (I did) before they released it for delivery. In England, they apparently don't need a prescription.

Anyway, this unit will help with some muscle pains but it not intended to block the pain signals like a TENS unit would do.

It's certainly worth the price with shipping ($25), though. The one I have that I ordered with my TENS costs well over $100. Just because this one on Woot is not that expensive doesn't mean it's not as good, so if you're looking for an E-Stim unit, I wouldn't pass this one up. I bought this one today so that my wife could have one for her own instead of borrowing (and often losing) mine.

time2testit wrote:Has anyone used this successfully for plantar fasciitis?

And those who have found bigger and not so expensive pads, how about posting some links please?

I haven't used it for PF, but I have had PF in the past. What worked for me was powerstep pinnacle insoles (the blue ones). I went from chronic pain while walking to having no pain within a couple of weeks.

t2000kw wrote:I meant to post this earlier today but ran out of time before leaving for work.

Apparently, this is not a TENS unit, though it bears some similarity to them. It is a electronic muscle stimulator, or E-Stim unit, like those used in Chiropractors' and perhaps some physical therapists' offices.

Download the manual and you will not see any reference to it being a TENS unit. TENS units are regulated in the US by the FDA. I know, because I bought one from England and had it shipped to the US, only to be stopped at US Customs by the FDA. I had to prove I had a prescription for the unit (I did) before they released it for delivery. In England, they apparently don't need a prescription.

Anyway, this unit will help with some muscle pains but it not intended to block the pain signals like a TENS unit would do.

It's certainly worth the price with shipping ($25), though. The one I have that I ordered with my TENS costs well over $100. Just because this one on Woot is not that expensive doesn't mean it's not as good, so if you're looking for an E-Stim unit, I wouldn't pass this one up. I bought this one today so that my wife could have one for her own instead of borrowing (and often losing) mine.

According to the Woot description and the product's "brochure," this is a TENS unit:

http://www.prosperacorp.com/pdfbrouchures/handheld/PL009_Electronic_Pulse.pdf

GeekyOne wrote:Can someone please verify if this is a TENS or an EMS unit? Also, what size pads come with this unit?

It's an electronic muscle stimulator (EMS or E-Stim) as you probably suspected.

I don't know what size pads you get with it but you will soon need fresh ones. I get mine from Austin Medical Supply and order online. They often offer free shipping.

http://austinmedical.net/category/1139488001/1/Electrodes.htm

You may find a less expensive source. You can choose the pad size when you order your replacements.

Note that this unit may or may not use standard TENS plugs on the wiring. It looks like standard but the pictures don't show a good top view. The TENS and E-stim (2 different units) I bought from England use a non-standard plug, so when I needed to replace mine (due to losing them), I had to buy from the same company. They weren't expensive, but I couldn't just conveniently go to a medical supply store and pick up replacements.

I wouldn't let uncertainty about the plugs/jacks stop you from making the purchase. But if you expected a TENS unit, a TENS unit it is not, despite the ad copy the by the usually very smart WOOT people. They missed the target on this one. It's the first time I've seen a product description that wasn't entirely accurate. But you would expect to pay a lot more than this even for a muscle stimulator, so it's a good price.

time2testit wrote:According to the Woot description and the product's "brochure," this is a TENS unit:

http://www.prosperacorp.com/pdfbrouchures/handheld/PL009_Electronic_Pulse.pdf

If that's the case, they may have some problems with the FDA and you may not receive your unit if you ordered it.

Fortunately, that is not the case. Search through that document you linked to and see if you find the word TENS, tens, or Tens anywhere in it. You won't, because the company that makes this device knows it is not and doesn't market it as such. Otherwise, they'd have to get pre-marketing approval from the FDA.

You will find it inside the word intensity, and that's about it. That's why the product manual (I have read it through) calls it an "Electronic Pulse Massager."

Yes, the Woot description DOES refer to it as both an Electronic Pulse Massager (in the title and 4 more times in the ad copy. They also refer to it as a TENS unit 4 times (once next to the word "Product" and 3 more times in the ad copy.

You'll find information similar to this in various places on the Internet that deal with US sales:

http://www.medword.com/MedwordStore/PCP/tens-faq.html

"TENS is a FDA regulated non-narcotic pain relief device."

EMS or E-stims are not regulated as such as they don't require a prescription for one.

http://www.painreductiontherapy.com/ten.php?cat=8

"All Tens units sold in the U.S. require a prescription from a licensed medical doctor. The prescription can be faxed, emailed or sent by mail to us. This is a requirement of the F.D.A."

Muscle stimulators are often confused with TENS units, by the way. The controls can even be identical. My TENS and E-Stim (EMS) units are made and marketed by the same company, use the same case and switch arrangement, and even a similar LCD display.

Sorry, but this is not a TENS. These do use the same electrical pads as TENS units do, though.

"Ergonomically designed for optimum comfort"


....I guess that means that my old DVD/VCR combo flipper is ergonomically designed as well.

t2000kw wrote:If that's the case, they may have some problems with the FDA and you may not receive your unit if you ordered it.

Fortunately, that is not the case. Search through that document you linked to and see if you find the word TENS, tens, or Tens anywhere in it. You won't, because the company that makes this device knows it is not and doesn't market it as such. Otherwise, they'd have to get pre-marketing approval from the FDA.

You will find it inside the word intensity, and that's about it. That's why the product manual (I have read it through) calls it an "Electronic Pulse Massager."

Yes, the Woot description DOES refer to it as both an Electronic Pulse Massager (in the title and 4 more times in the ad copy. They also refer to it as a TENS unit 4 times (once next to the word "Product" and 3 more times in the ad copy.

You'll find information similar to this in various places on the Internet that deal with US sales:

http://www.medword.com/MedwordStore/PCP/tens-faq.html

"TENS is a FDA regulated non-narcotic pain relief device."

EMS or E-stims are not regulated as such as they don't require a prescription for one.

http://www.painreductiontherapy.com/ten.php?cat=8

"All Tens units sold in the U.S. require a prescription from a licensed medical doctor. The prescription can be faxed, emailed or sent by mail to us. This is a requirement of the F.D.A."

Muscle stimulators are often confused with TENS units, by the way. The controls can even be identical. My TENS and E-Stim (EMS) units are made and marketed by the same company, use the same case and switch arrangement, and even a similar LCD display.

Sorry, but this is not a TENS. These do use the same electrical pads as TENS units do, though.

Huh? You don't have to search very far. The second sentence in the brochure reads: "The Prospera Electronic Pulse Massager is a Transcutaneous Electrical Nerve Stimulations unit or TENS UNITS."

My chiropractor uses a machine with these pads and they are amazing! He puts on wet paper towel squares to hold on the pads. Is it safe to do that with this or would that even work. He might have a different kind of padding?

fuzzypeaches wrote:I was wondering if only 1 pad thingy could be used! ;)

You need at least 2 to complete the circuit. For a larger area, use all 4 in a criss-cross arrangement (diagonally). The product manual (page 10) shows using only 2, so it will work that way. You DON'T want to arrange them in any way that current goes through the heart, though! If you're using it for back pain over anything but a pinpoint area, try arranging the 4 pads in such a way that it criss-crosses over that area. You can also try just putting 2 from the one wire on top and 2 from the other on the bottom, or 2 on one side and 2 on the other. See what works best for you (and what's the easiest for you to place them behind your back).

time2testit wrote:Huh? You don't have to search very far. The second sentence in the brochure reads: "The Prospera Electronic Pulse Massager is a Transcutaneous Electrical Nerve Stimulations unit or TENS UNITS."

It doesn't read as such. Your quote is from the Woot description under "product features."

Here are the first two sentences from the product brochure:

"Prospera’s PL009 Electronic Pulse Massager is a user friendly product. Electronic Pulse
Massager delivers electric impulses to tired and sore muscles. These impulses are
generated by the device and delivered through electrodes to the skin in direct proximity
to the target muscles."

Sorry, but it's not in there!

t2000kw wrote:It doesn't read as such. Your quote is from the Woot description under "product features."

Here are the first two sentences from the product brochure:

"Prospera’s PL009 Electronic Pulse Massager is a user friendly product. Electronic Pulse
Massager delivers electric impulses to tired and sore muscles. These impulses are
generated by the device and delivered through electrodes to the skin in direct proximity
to the target muscles."

Sorry, but it's not in there!

Seriously? Did you even bother to open the brochure link I posted (from the very first post in the discussion here) before you tell everyone (and me) that it is not there? It is the second sentence in their PDF brochure.

I don't know what brochure you are reading. From what I can tell, you are in fact quoting the "product manual" which was linked in the Woot description, and not the product brochure, which does not have a link in the Woot description.

You'll note the Woot description is not what I quoted. The Woot description under "Features" is: "The Prospera Electronic Pulse Massager is a Transcutaneous Electrical Nerve Stimulation unit (TENS)"

The Woot description is similar to the brochure, but not the identical wording (which is why I quoted the company's brochure and not the Woot description).

Bottom line is I have no idea what this thing is, but at least we should understand that the company's brochure calls it a TENS unit.