Medical Device or Not?

[holsteinatlanta]

I have a portable Home Oxygen Concentrator I wanted to list.  Not sure if it is a RX only device.  Going through the ebay knowledge base going from page to page looking for info.  There is one page with a FDA email address which I just wrote to and asked.  Anyone know if it is a restricted item and where I can  find an exact answer?

Thanks

[pjcdn2005]

Oxygen concentrators are on ebays not allowed list.

https://www.ebay.com/help/policies/prohibited-restricted-items/medicine-medical-devices-healthcare-p...

Not Allowed

• Oxygen concentrators, oxygen compressors, oxygen conservers and their accessories that require a prescription

[gracieallen01]

From a google search (google can be your friend)

"Do you need a prescription for an oxygen concentrator?

A physician's prescription is mandatory. It is federally illegal for anyone to sell or rent medical grade oxygen without a valid, signed prescription. ... However, very often, the portable oxygen concentrator's supplier can contact the physician on the patient's behalf and complete the required paperwork."

[holsteinatlanta]

Thank you guys. The FDA did reply and say it was okay to sell, but holding off for now.


Dear Andrew,
Thank you for contacting the Division of Industry and Consumer Education (DICE) at FDA's Center for Devices and Radiological Health (CDRH) gov e-mail account.
Yes you can sell your previously owned oxygen concentration as long as you obtained from it within the U.S., and it was made by a manufacturer that is registered and listed with FDA.
For regulatory information about your medical device of interest, please search the Product Classification, Premarket Notification 510(k) and Establishment Registration & Device Listing databases to check if a device similar to your product is listed with the U.S. Food and Drug Administration (FDA). The product code for oxygen concentrator is CAW. I found a list of oxygen concentrator related devices on the Premarket Notification 510(k) database. You can look through the search results to see if you can find your device of interest. The 510(k) summary has information on the prescription use. An oxygen concentrator is a prescription use device. For example, the device summary for Gce Zen-O Portable Oxygen Concentrator shows it is a prescription use device.

[castlemagicmemories]

Since it is banned on ebay, you would be wise to not sell it.  You could place your selling privileges in jeopardy.

[gkyn29]

---

@holsteinatlanta wrote:
Thank you guys. The FDA did reply and say it was okay to sell, but holding off for now.


Dear Andrew,
Thank you for contacting the Division of Industry and Consumer Education (DICE) at FDA's Center for Devices and Radiological Health (CDRH) gov e-mail account.
Yes you can sell your previously owned oxygen concentration as long as you obtained from it within the U.S., and it was made by a manufacturer that is registered and listed with FDA.
For regulatory information about your medical device of interest, please search the Product Classification, Premarket Notification 510(k) and Establishment Registration & Device Listing databases to check if a device similar to your product is listed with the U.S. Food and Drug Administration (FDA). The product code for oxygen concentrator is CAW. I found a list of oxygen concentrator related devices on the Premarket Notification 510(k) database. You can look through the search results to see if you can find your device of interest. The 510(k) summary has information on the prescription use. An oxygen concentrator is a prescription use device. For example, the device summary for Gce Zen-O Portable Oxygen Concentrator shows it is a prescription use device.

---

Doesn't matter what the FDA says if ebay says No.

[missjen831 · Accepted solution]

It does not matter what the FDA says when it comes to selling here. Home concentrators require a prescription and cannot be sold on ebay, ebays rules.

[gracieallen01]

Yes, you can sell it, though it doesn't state under what conditions or to whom - but, not on ebay.

Do you have to have a license to sell it?  If not, can you sell it to anyone or must it be to someone with a license to sell/handle them or prescription from a physician to use/buy one?

[rustcity]

Actually, it does matter what the FDA rules that can be legally sold or can be used as a medical device, and all such devices will have received a 510k notification number starting with a "k".  Such devices can be legally sold using a completed statement of intent from the Buyer.  Use of the medical device, such as an oxygen concentrator, without a medical provider's prescription carries substantial criminal penalties.

Ebay can impose whatever restrictrive rules that it wants.   However, ebay applies these restrictive rules rather capriciously.  Yesterday, I listed an DeVilbiss O2 concentrator, one that has received the required 510k FDA notification, and it was promptly removed by ebay.  Meanwhile, ebay has allowed dozens of O2 concentrators to be listed and SOLD here in the USA.  Several were brands commonly sold in the USA and obviously have th required 510k notification,  But by far, NONE of the others have received this.  One company even claims their model has it, yet says their O2 Conc is a generic model mfg in China.  Need more be said ebay is allowing some to sell illegal items to USA customers. 

To wit, listings

173495060111, 173482511276, 132755358251, 332661035107, 323399060032, 142913988662, 282549733656, 392104320244, 113206750833, 183380372523, 142915433138, 183390610792, 323403228342, 113206650049, 323411009087, 292632413474, 292664969890, 263879789721, 153149173186, 183397365477, 113208404946, 113208446333, 163033280395, 263266984083, 273235503510, 112949401673, 273134386234, 182518404367,

222981871576, 323399059670, 182878311738, 273244860034, 162801167743, 272699862644, 323341930371,

263348788741, 252852192043, 253670333064, 401473972324, 132465552451, 323261570836, 223046181806, 323333689236, 323261562598, 222984203179, 282908784620, 162801174706, 252852082802, 332569219707, 162921151617, 332569209974, 163075892422, 192453720945, 232769552386, 162921172093, 232872809528, 332653962689, 183317974050, 232769516343, 263850406191, 173403588538, 253454920175, 332569234538,

183318018621,     192581033414,     332675687956,   273227310507,  232762355293, 173403686405, 332571479186, 173226165420, 192589583536, 142875687488, 232769573403.

[spufee]

Ebay just removed a portable oxygen concentrator that I had on today.  These are not RX devices, as long as you have the money and your not wanting your insurance company to be paying for it you can buy one without a RX.  I know, I bought one from an oxygen company and now I want to sell it.  A lot of large cities actually have EGADS!, oxygen bars, where you can go in and sniff oxygen, no RX required.  

[extrememobility]

I would post that item on CL ! no you will not get the exposure you will get here but then you do not have to deal with shipping it either?