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FDA 510(k)

BTL-199

K-Number: K250309 · 2025-08-07

ApplicantBTL Industries, Inc.
Decision Date2025-08-07
Product CodeQPL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BTL-199 is the device name listed in this FDA 510(k) record. The listed applicant is BTL Industries, Inc.. It received FDA 510(k) clearance on 2025-08-07 under 510(k) number K250309. The device is classified under product code QPL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BTL-199?

BTL-199 is a medical device that received FDA 510(k) clearance on 2025-08-07. The listed applicant is BTL Industries, Inc.. The 510(k) number is K250309.

When did BTL-199 receive FDA 510(k) clearance?

BTL-199 received FDA 510(k) clearance on 2025-08-07, under 510(k) number K250309.

Who is the listed applicant for BTL-199?

The FDA 510(k) record lists BTL Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BTL-199?

The FDA product code for BTL-199 is QPL.

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Other records listing BTL Industries, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252963BTL-899TTK253750BTL-785NEHK252561BTL-754FFK243290BTL-785MJK241516BTL-398K241270BTL-754

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Related Devices (Code: QPL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250286Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1)The Magstim Company LimitedK241785StarFormer (M008-3T)Fotona D.O.O.K233364Axon TherapyNeuralace Medical, Inc.K230014MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOptionTonica Elektronik A/SK210021Axon TherapyNeuralace Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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