Cleared Traditional

bite away neo

K220514 · mibeTec GmbH · Physical Medicine
Jun 2022
Decision
121d
Days
Class 2
Risk

About This 510(k) Submission

K220514 is an FDA 510(k) clearance for the bite away neo, a Pad, Heating, Powered (Class II — Special Controls, product code IRT), submitted by mibeTec GmbH (Brehna, DE). The FDA issued a Cleared decision on June 23, 2022, 121 days after receiving the submission on February 22, 2022. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5740.

Submission Details

510(k) Number K220514 FDA.gov
FDA Decision Cleared SESE
Date Received February 22, 2022
Decision Date June 23, 2022
Days to Decision 121 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code IRT — Pad, Heating, Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5740