FDA and EbayPosted by John H on 10/05/03 at 16:29 (132326)
I received a message from eBay that a TENS unit and Muscle Stimulator had been pulled off the for sale board as these are medical devices controlled by the FDA. I was wondering how these prescription devices were being sold?
There are some TENS units that are still on there but are not the ones made by EMPI who probably watches eBay closely as they charge $600-$700 for their units and I saw a couple being advertised at $100.
Re: FDA and EbayEd Davis, DPM on 10/05/03 at 16:35 (132327)
I don't think that the resources exist to police isolated sales of prescription items.
Re: FDA and EbayDr. Z on 10/05/03 at 18:05 (132334)
Usually you need a physician's prescription to obtain these specific devices
Re: FDA and EbayDorothy on 10/06/03 at 01:16 (132383)
John H. ~ Well, that's very interesting. I am sorry to hear that.
Re: FDA and EbayDorothy on 10/06/03 at 01:18 (132384)
I forgot to add: if only the FDA actually watched out for our health instead of primarily watching out for the health of the bottom line of corporations.
Re: FDA and Ebayjohn h on 10/06/03 at 08:17 (132409)
Ed: If someone had a prescription device like a TENS unit and no longer had need for it they should be able to sell it. The question is how would they legally sell it. I think a TENS unit is in the same class as an ESWT unit. Is that right or wrong. Dr Z when you sold your Orby did you or the buyer have to fill out any special FDA forms?
Re: FDA and EbayDr. Z on 10/06/03 at 10:12 (132424)
Its a long story. I still own Mr. Orbie.
Re: FDA and EbayEd Davis, DPM on 10/06/03 at 13:40 (132448)
To the best of my knowledge, prescription devices cannot be sold from individual to individual. Practically speaking, enforcement of this is likely to be minimal.
Re: FDA and EbayEd Davis, DPM on 10/06/03 at 13:41 (132449)
Amen to that.
Re: FDA and EbayEd Davis, DPM on 10/06/03 at 13:44 (132451)
What did you do with your Orbie? You could just place it on a boat of the Jersey coast, just outside the 12 mile limit and get lots of use out of it. Bring patients to the boat on weekends for ESWT while you fish -- and you get to write off the boat.
Re: FDA and EbayJohn H on 10/06/03 at 15:45 (132476)
Ed: I like that idea. Fish,wine,the orby. I might be willing to pay your price Dr. Z. The boat needs to be very nice however. No barge.
Re: FDA and EbayJohn H on 10/06/03 at 15:46 (132477)
Dr. Z I may still have one of your spark gap plugs.
Re: FDA and EbayJohn H on 10/06/03 at 15:52 (132481)
ED I saw where one of the TENS units did sell and one of the prescription muscle stimulators did sell so they did not get them all. A quality Empi Tens unit sells for around $600-$700. The used Empi on eBay sold for $125. The new $2000 muscle stimulator/tens sold for $800. I know this unit has a computer chip in it that is programed at the manufacturer for your particualr condition and you get a new one after you have had it for 2 months. I hope the buyer does not find that the old chip disables his device after two months and as not an original buyer cannot get a new chip???
Re: FDA and Ebaymisslulu on 10/06/03 at 16:03 (132483)
Hi ya'll, just some input:
A relative bought a tens from a co-worker for $60 (new).
Not sure about the legality of it, but when you are in pain 24-7 I guess you don't worry about anything but pain relief.
Anyways....I borrowed it once when I had back spasms and I had somewhere very important to go......IT HELPED TREMENDOUSLY. It got me through the day!
I wish I had one for my very own.
Re: FDA and EbayDr. Z on 10/06/03 at 22:22 (132531)
The orbie is on vacation waiting for a new FDA ticket back to the USA.
Re: FDA and EbayEd Davis, DPM on 10/07/03 at 00:56 (132552)
I think $600 to $700 is a bit of a high mark up for a TENS. Sometimes devices such as this are marked up because, for some reason, third parties generously reimburse for such devices-- one of the quirks of the system that I cannot explain. Most devices are controllable in terms of frequency and intensity. Perhaps you are referring to a device that is pre-programmed.
I am not sure most people need the bells and whistles though and non-progammed 4 channel units should be available in the $300 range, new.
Re: FDA and Ebayjohn h on 10/07/03 at 10:28 (132576)
Ed: The combination Muscle Stimulator/Tens unit that my daughter is trying out has a removable computer chip. Based on the information you give your Doctor the company programs the chip. You still have certain controls available to you such as intensity and a couple of others. If your Doctor so recommends you can take the chip out and have it reprogramed. I do not know exactly what they are putting on the chip but it certainly gives the manufacturer control over the device. It could easily be programed to shut the device down each year for reprograming and that way the owner could never sell the device. The retail device on this unit is $2700. Monthly rental can be from $35-$300. Many Insurance Companies pay for them but negotiate the price down. Medicare will not pay for them as they are considered durable medical equipment so the rep said if you are medicare insured you can get a 3 month trial during which time they will submit a medicare clain which will be rejected. You will not have to pay during this period. You can then negotiate with the manufacturer on a price. She would not tell me about how much one could negotiate them down but she thought as much as 50%. This unit is not something you wear to work but use at home two times a day for 45 minutes. It goes though two cycles. One of deem muscle stimulation (you can control the intensity) and then goes into the pain relieving mode. My daughter reported her muscles were really sore after the first few treatments but are now more adjusted. She reports it is very much like a back rub. You have 8 pads placed on your back at locations directed by your Doctor and the device can put out a lot of energy causing muscle contractions of any intensity you can tolerate. Many hospitals use these divices for pain control and muscle rehab after such surgeries as knee and back.