Cleared Traditional

BTL-094

K221865 · BTL Industries, Inc. · Physical Medicine
Apr 2023
Decision
291d
Days
Class 1
Risk

About This 510(k) Submission

K221865 is an FDA 510(k) clearance for the BTL-094, a Massager, Therapeutic, Electric (Class I — General Controls, product code ISA), submitted by BTL Industries, Inc. (Malborough, US). The FDA issued a Cleared decision on April 14, 2023, 291 days after receiving the submission on June 27, 2022. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5660.

Submission Details

510(k) Number K221865 FDA.gov
FDA Decision Cleared SESE
Date Received June 27, 2022
Decision Date April 14, 2023
Days to Decision 291 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code ISA — Massager, Therapeutic, Electric
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.5660

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