Cleared Traditional

BTL-199

K250309 · BTL Industries, Inc. · Physical Medicine

Aug 2025

Decision

185d

Days

Class 2

Risk

About This 510(k) Submission

K250309 is an FDA 510(k) clearance for the BTL-199, a Electromagnetic Stimulator, Pain Relief (Class II — Special Controls, product code QPL), submitted by BTL Industries, Inc. (Malborough, US). The FDA issued a Cleared decision on August 7, 2025, 185 days after receiving the submission on February 3, 2025. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number	K250309 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 03, 2025
Decision Date	August 07, 2025
Days to Decision	185 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF

Device Classification

Product Code	QPL — Electromagnetic Stimulator, Pain Relief
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.5890
Definition	Intended To Apply A Magnetic-field Induced Electrical Current To Treat Pain.