Cleared Traditional

Polar Care Wave

K183702 · Breg, Inc. · Physical Medicine
Mar 2019
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K183702 is an FDA 510(k) clearance for the Polar Care Wave, a Massager, Powered Inflatable Tube (Class II — Special Controls, product code IRP), submitted by Breg, Inc. (Carlsbad, US). The FDA issued a Cleared decision on March 1, 2019, 60 days after receiving the submission on December 31, 2018. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5650.

Submission Details

510(k) Number K183702 FDA.gov
FDA Decision Cleared SESE
Date Received December 31, 2018
Decision Date March 01, 2019
Days to Decision 60 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code IRP — Massager, Powered Inflatable Tube
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5650

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