How to prove to Amazon that my product qualifies for a 510 K exemption?
Hi everyone, one of my products has been recognized by Amazon as needing to provide a 510K certification.
My product is a massage type appliance that meets the Massager, Therapeutic, Electric in Regulation Number 890.5660 from FDA.
But how do I prove to Amazon that my product is Massager, Therapeutic, Electric and exempt from 510K certification?
3 replies
Seller_4zBzdtgCyS9EI
You are selling a "wrap around" massage belt.
§ 890.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
The exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is only to the extent that the device has existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the case of in vitro diagnostic devices, only to the extent that misdiagnosis as a result of using the device would not be associated with high morbidity or mortality. Accordingly, manufacturers of any commercially distributed class I or II device for which FDA has granted an exemption from the requirement of premarket notification must still submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the device when:
(b) The modified device operates using a different fundamental scientific technology than a legally marketed device in that generic type of device; e.g., a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade
Basically, only the FDA can decide if this product is considered a "standard massager" or fundamentally different....
Have you contacted the FDA and checked with them?
Seller_tKPfcAMrOjaF6
Actually,the product I was affected by wasn't that belt, but another product who wasn't able to be seen due to review issues.
Thank you for your suggestion, I will try to contact the FDA staff and hopefully get a response!
Thank you.