Sleep apnea product company Zyppah reported on Monday the receipt of the 510k clearance from the US FDA for the launch of the first OTC (over-the-counter) dual action anti-snoring device Zyppah.
As of 21 January 2019, the company and its creator, Dr Jonathan Greenburg, DDS, received the US FDA registration #K182312 for Zyppah, which has been on the market for six years.
The company said the US FDA's certification included a "first" ranking when compared against the category monograph to feature a wholly unique, dual-action feature that advances the mandible while repositioning the tongue to keep it from blocking the airway; the reason snoring occurs.
In connection with the launch, Zyppah retails for USD99.95 and is available on Zyppah.com and Amazon.com.
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