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FDA 510(k)

BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS)

K-Number: K160378 · 2017-08-25

ApplicantBrh Medical , Ltd.
Decision Date2017-08-25
Product CodeIMI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) is the device name listed in this FDA 510(k) record. The listed applicant is Brh Medical , Ltd.. It received FDA 510(k) clearance on 2017-08-25 under 510(k) number K160378. The device is classified under product code IMI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS)?

BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) is a medical device that received FDA 510(k) clearance on 2017-08-25. The listed applicant is Brh Medical , Ltd.. The 510(k) number is K160378.

When did BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) receive FDA 510(k) clearance?

BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) received FDA 510(k) clearance on 2017-08-25, under 510(k) number K160378.

Who is the listed applicant for BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS)?

The FDA 510(k) record lists Brh Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS)?

The FDA product code for BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) is IMI.

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.

NCT06875206Visual Restoration Using Focused Ultrasound Stimulation and Immersive Virtual Reality After StrokeNOT_YET_RECRUITINGNCT06968663Transcranial Magnetic Stimulation + Language Therapy to Treat Subacute AphasiaRECRUITING

Related Devices (Code: IMI)

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.

K240788Ultrasound StimulatorJkh Health Co., Ltd.K230472Sonopuls 190Enraf-Nonius, B.V.K222098ManaSport+Manamed, Inc.K210284ManaSportManamed, Inc.K202788Sonomed IV, Sonomed VCarci Industria E Comercio DE Aparelhos Cirurgicos E OrtoK161628JAS Pulse(TM) Ultrasonic TherapyBonutti Research, 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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