Cleared Traditional

BTL-899MS

K240234 · BTL Industries, Inc. · Physical Medicine
Aug 2024
Decision
201d
Days
Class 2
Risk

About This 510(k) Submission

K240234 is an FDA 510(k) clearance for the BTL-899MS, a Stimulator, Muscle, Powered (Class II — Special Controls, product code IPF), submitted by BTL Industries, Inc. (Malborough, US). The FDA issued a Cleared decision on August 17, 2024, 201 days after receiving the submission on January 29, 2024. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number K240234 FDA.gov
FDA Decision Cleared SESE
Date Received January 29, 2024
Decision Date August 17, 2024
Days to Decision 201 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code IPF — Stimulator, Muscle, Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5850