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-995-rTMS

K-Number: K212723 · 2022-03-04

ApplicantBTL Industries, Inc.
Decision Date2022-03-04
Product CodeOBP
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BTL-995-rTMS 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 2022-03-04 under 510(k) number K212723. The device is classified under product code OBP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BTL-995-rTMS?

BTL-995-rTMS is a medical device that received FDA 510(k) clearance on 2022-03-04. The listed applicant is BTL Industries, Inc.. The 510(k) number is K212723.

When did BTL-995-rTMS receive FDA 510(k) clearance?

BTL-995-rTMS received FDA 510(k) clearance on 2022-03-04, under 510(k) number K212723.

Who is the listed applicant for BTL-995-rTMS?

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-995-rTMS?

The FDA product code for BTL-995-rTMS is OBP.

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.

NCT07679750rTMS Device for Improvement of Obsessive and Compulsive BehaviorsNOT_YET_RECRUITINGNCT07624539Device 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_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: OBP)

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.

K261228QuickVision Ultimate rTMSBrain Ultimate, Inc.K260560Apollo TMS Therapy System;Apollo light TMS Therapy SystemMag & More GmbHK260189MagVenture Accelerated TMS (aTMS) Therapy SystemTonica Elektronik A/SK253098Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)Nexstim OyjK252358Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)Nexstim OyjK251653SPRY TMS Therapy System (0550)Soterix 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.

↑