Hey guys!
Hope you're all doing well! I just wanted to vent and ask for some advice from the community. It’s been 79 days since two of my ASINs were disabled—B0CWQVVLDJ and B0CRLVD5QJ. My case ID is 16519740161, which I opened on October 21st, 2024. I tried reaching out through email but struggling to get a non-automated answer.
What’s really getting to me is that other sellers are actively selling the exact same items I sell, individually, but they don’t seem to be required to provide 510(k) documentation like I am. Their listings are still active, while mine are disabled.
The product I sell is titled ‘Portable Oxygen Tank Complete Set - Made in USA | Lightweight & Easy to Use,’ which is essentially a ‘kit’—a combination of an oxygen tank and accessories. These accessories are already being sold individually by other sellers on Amazon, just under different brand names. I’ve designed and marketed this kit to make it easier for people to use an oxygen tank similarly in places like Mexico City, where oxygen tanks and their accessories are frequently used and purchased in bundled kits.
The "kit" or "complete set" I listed includes accessories that attach to an oxygen tank, making it portable and user-friendly. The components in the kit are classified as Class I under FDA guidelines and are 510(k) exempt based on their classifications. They’re not intended for professional use, meaning they can be sold OTC (Over-the-Counter) without needing 510(k) clearance, you can go and purchase all the individual accessories and an oxygen tank at a local medical supply store for cash and don't need any license or documentation to purchase said items.
I understand that some policies might treat the whole kit as a professional-use-only device, but the individual pieces in my kit are each exempt on their own. They are currently sold separately online by different sellers, just under different brand names. So, the way I’ve packaged and marketed them shouldn’t require 510(k) documentation, since each piece is exempt due to its Class I classification.
On top of that, the business I work with is a registered FDA establishment—you can look it up on the FDA.gov website. I’ve tried explaining all this to an Amazon rep, but no luck. I’ve provided detailed information about all the products I sell and have images ready to show exactly what’s in the kit.
Here’s a quick breakdown of the components I sell:
1. XXXX REGULATOR & OXYGEN TANK / GAS CYLINDER
Proprietary Name: XXXX REGULATOR
Classification Name: REGULATOR, PRESSURE, GAS CYLINDER
Product Code: CAN
Device Class: Class 1
Regulation Number: 868.2700
Registered Establishment: XXXX Inc
Registered Establishment Number: 1650364
510(k) Exempt due to Class 1 classification.
(This is the oxygen tank and regulator that attaches to the top of the oxygen tank.)
2. CYLINDER CART for D/E SIZE OXYGEN TANK / CYLINDER
Proprietary Name: CYLINDER CART
Classification Name: CART, EMERGENCY, CARDIOPULMONARY (EXCLUDING EQUIPMENT)
Product Code: BZN
Device Class: Class 1
Regulation Number: 886.6175
510(k) Exempt due to Class 1 classification.
& oxygen face masks / oxygen cannulas which are 510k exempt and can be purchased on amazon.com or at a local medical supply store over the counter (OTC)
Essentially, if an Amazon rep looks at my listing, they’ll see it’s an oxygen tank with various accessories. All of these individual items are actively being sold both FBM and FBA , just separately—not bundled together in a kit like mine.
So, I’m asking—what do you all suggest I do next? How can I get this sorted out? Has anyone else dealt with something similar?
Thanks so much for hearing me out! I’d really appreciate any advice or suggestions you might have.