Cleared Traditional

BTL-785BNF-E

K242532 · BTL Industries, Inc. · Neurology
Dec 2024
Decision
109d
Days
Class 2
Risk

About This 510(k) Submission

K242532 is an FDA 510(k) clearance for the BTL-785BNF-E, a Stimulator, Transcutaneous Electrical, Aesthetic Purposes (Class II — Special Controls, product code NFO), submitted by BTL Industries, Inc. (Malborough, US). The FDA issued a Cleared decision on December 13, 2024, 109 days after receiving the submission on August 26, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number K242532 FDA.gov
FDA Decision Cleared SESE
Date Received August 26, 2024
Decision Date December 13, 2024
Days to Decision 109 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code NFO — Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5890

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