Cleared Traditional

Bite Away

K160943 · Riemser Pharma · Physical Medicine

Aug 2016

Decision

143d

Days

Class 2

Risk

About This 510(k) Submission

K160943 is an FDA 510(k) clearance for the Bite Away, a Pad, Heating, Powered (Class II — Special Controls, product code IRT), submitted by Riemser Pharma (Greifswald-Insel Riems, DE). The FDA issued a Cleared decision on August 26, 2016, 143 days after receiving the submission on April 5, 2016. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5740.

Submission Details

510(k) Number	K160943 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 05, 2016
Decision Date	August 26, 2016
Days to Decision	143 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF