Cleared Traditional

K160378 - BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS)
(FDA 510(k) Clearance)

K160378 · Brh Medical , Ltd. · Physical Medicine
Aug 2017
Decision
562d
Days
Class 2
Risk

K160378 is an FDA 510(k) clearance for the BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS), a Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat (Class II — Special Controls, product code IMI), submitted by Brh Medical , Ltd. (Jerusalem, IL). The FDA issued a Cleared decision on August 25, 2017, 562 days after receiving the submission on February 10, 2016. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5300.

Submission Details

510(k) Number K160378 FDA.gov
FDA Decision Cleared SESE
Date Received February 10, 2016
Decision Date August 25, 2017
Days to Decision 562 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code IMI — Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5300