BTL-199— 510(k) K250309

Substantially Equivalent

BTL Industries, Inc.

FDA 510(k) clearance K250309 for BTL-199, Substantially Equivalent on 2025-08-07. Applicant: BTL Industries, Inc.. Device class: 2.

Clearance details

Applicant: BTL Industries, Inc.
Product code: Code QPL
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2025-02-03
Decision date: 2025-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marlborough, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QPL

K250286 — Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1)2025-07-03
K241785 — StarFormer (M008-3T)2025-03-27
K233364 — Axon Therapy2024-01-10
K230014 — MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption2023-08-25
K210021 — Axon Therapy2021-06-11

More clearances from BTL Industries, Inc.

Data sourced from openFDA. This site is unofficial and independent of the FDA.