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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 a medical device manufactured by Brh Medical , Ltd.. It received FDA 510(k) clearance on 2017-08-25 under approval 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. It is manufactured by Brh Medical , Ltd.. The 510(k) number is K160378.

When was BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) approved by the FDA?

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

What company makes BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS)?

BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) is manufactured by Brh Medical , Ltd..

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

NCT06868914 Phase I Trial of High-Density Theta Burst Stimulation (hdTBS) NOT_YET_RECRUITING NCT07099092 Causal Mechanisms of Odor-Guided Behavior in Humans NOT_YET_RECRUITING NCT03280862 DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS COMPLETED NCT06561828 Developing Transcranial Neuromodulation Protocols for Learning and Decision-Making RECRUITING NCT06426498 tFUS Induced Transient Scotoma for Individual Dosing RECRUITING NCT07614945 Effect of Reflexology on Pain and Sleep Disorders in Females With Fibromyalgia NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41470022 Low-intensity pulsed ultrasound for peripheral nerve regeneration: mechanobiological mechanisms and translational potential. Journal of translational medicine (2025) PMID: 39736921 US regulatory compliance for medical combination products: an overview. Frontiers in medical technology (2024)

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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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