BTL-785MJ— 510(k) K243290

Substantially Equivalent

BTL Industries, Inc.

FDA 510(k) clearance K243290 for BTL-785MJ, Substantially Equivalent on 2025-05-09. Applicant: BTL Industries, Inc.. Device class: 2.

Clearance details

Applicant: BTL Industries, Inc.
Product code: Code NUW
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 2024-10-18
Decision date: 2025-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marlborough, MA, US

Download summary PDF View on FDA.gov ↗

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