Cleared Traditional

BTL-703

K182363 · BTL Industries, Inc. · Physical Medicine
Jan 2019
Decision
147d
Days
Class 2
Risk

About This 510(k) Submission

K182363 is an FDA 510(k) clearance for the BTL-703, a Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat (Class II — Special Controls, product code IMJ), submitted by BTL Industries, Inc. (Malborough, US). The FDA issued a Cleared decision on January 24, 2019, 147 days after receiving the submission on August 30, 2018. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5290.

Submission Details

510(k) Number K182363 FDA.gov
FDA Decision Cleared SESE
Date Received August 30, 2018
Decision Date January 24, 2019
Days to Decision 147 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code IMJ — Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5290