Clearance Summary
BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS) received FDA 510(k) clearance under submission number K160378, sponsored by Brh Medical , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2017-08-25.
- Submission: K160378
- Applicant / Sponsor: Brh Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5300
- Decision date: 2017-08-25
Classification & Regulation
This clearance is catalogued under FDA product code IMI and 21 CFR 890.5300, within the Physical Medicine review panel as a Class II device.