After six years on the market, Zyppah has been granted US Food and Drug Administration (FDA) clearances to be made available over-the-counter (OTC) via third-party retail marketplaces.
“As a Class 2 medical device, which we were, you can sell it on your website directly to consumers BUT you cannot sell through a third party (such as Amazon or any retail store as in Costco, Target, WalMart, pharmacies, supermarkets, etc),” explains creator Jonathan Greenburg, DDS, via email to Sleep Review. “With the OTC approval, we can now sell everywhere in retail.”
As noted in the FDA #K182312, “The Zyppah Anti-Snoring Appliance is intended for use by adults (18 years or older) as an aid to reduce snoring. Biocompatibility testing results demonstrated that Zyppah is biocompatible under ISO 10993, including cytotoxicity, sensitization, and irritation testing. The device was shown to meet the requirements of the ISO 10993 guidelines for each of these tests. All materials used in the device are certified USP Class VI and used in many other currently marketed medical devices.”
Zyppah is a patented dual-action mouthpiece featuring both a mandible advancer and a “seat belt for the tongue” to keep the tongue from blocking the airway. NBA Hall of Famer Shaquille O’Neal serves as a global ambassador for the product. It retails for $99.95.
from Sleep Review http://www.sleepreviewmag.com/2019/04/zyppah-gets-fda-counter-510k-nod-allowing-sell-anti-snoring-oral-appliance-via-third-party-retail-marketplaces/