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

FDA 510(k)

BTL-99-OC

K-Number: K230657 · 2024-02-01

ApplicantBTL Industries, Inc.
Decision Date2024-02-01
Product CodeQCI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BTL-99-OC 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 2024-02-01 under 510(k) number K230657. The device is classified under product code QCI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BTL-99-OC?

BTL-99-OC is a medical device that received FDA 510(k) clearance on 2024-02-01. The listed applicant is BTL Industries, Inc.. The 510(k) number is K230657.

When did BTL-99-OC receive FDA 510(k) clearance?

BTL-99-OC received FDA 510(k) clearance on 2024-02-01, under 510(k) number K230657.

Who is the listed applicant for BTL-99-OC?

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-99-OC?

The FDA product code for BTL-99-OC is QCI.

Related Clinical Trials

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.

NCT07624539Device for Alleviating Temporomandibular Joint (TMJ) PainCOMPLETEDNCT07661082Safety and Efficacy of the BTL-043 Device in Alleviating Back PainCOMPLETEDNCT07661121EMVITAL + EMFACE Combination Therapy for Temporomandibular Joint (TMJ) Pain ReliefACTIVE_NOT_RECRUITINGNCT07679750rTMS Device for Improvement of Obsessive and Compulsive BehaviorsNOT_YET_RECRUITINGNCT07698639Anti-Gravity Treadmill and Electromagnetic Stimulation in Stroke RehabilitationCOMPLETEDNCT07700433Safety and Efficacy of the BTL-043 and BTL-899 Devices in Alleviating Back PainACTIVE_NOT_RECRUITING

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-754FFK250309BTL-199K243290BTL-785MJK241516BTL-398

View all 34 devices →

Related Devices (Code: QCI)

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.

K260402MeRT SystemWave NeuroscienceK243459Ultimate rTMS for OCD (M-series)Brain Ultimate, Inc.K233742CloudTMS Edge for OCDTeleemg, LLCK231350OCD MT Cap (85-00397-000)NeuroneticsK221129CloudTMS for OCDTeleemg, LLCK212289NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStarNeuronetics, 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.

↑