Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BTL-899M

K-Number: K232937 · 2023-12-26

ApplicantBTL Industries, Inc.
Decision Date2023-12-26
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

BTL-899M is a medical device manufactured by BTL Industries, Inc.. It received FDA 510(k) clearance on 2023-12-26 under approval number K232937. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BTL-899M?

BTL-899M is a medical device that received FDA 510(k) clearance on 2023-12-26. It is manufactured by BTL Industries, Inc.. The 510(k) number is K232937.

When was BTL-899M approved by the FDA?

BTL-899M received FDA 510(k) clearance on 2023-12-26, under approval number K232937.

What company makes BTL-899M?

BTL-899M is manufactured by BTL Industries, Inc..

What is the FDA product code for BTL-899M?

The FDA product code for BTL-899M is IPF.

Other Devices by BTL Industries, Inc.

K162010HPM-6000U K160992HPM-6000 K161551TR-100 K152731XP1100 RF K163165AM-100 K163176Exilis XP II

View all 33 devices →

Related Devices (Code: IPF)

K160614Xcite Clinical StationRestorative Therapies, Inc. K163067CyMedica e-vive™ System; CY-1000Cymedica Orthopedics, Inc. K160992HPM-6000BTL Industries, Inc. K151922StimSox(TM) SystemStimmed, LLC K153696Chattanooga Revolution WirelessDjo, LLC K160299geko(TM) Plus R-2 Neuromuscular StimulatorFirstkind Limited

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.

↑