Clearance Summary
Wireless TENS/EMS, Bruno, Aela received FDA 510(k) clearance under submission number K220997, sponsored by Zmi Elecronics , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2022-09-01.
- Submission: K220997
- Applicant / Sponsor: Zmi Elecronics , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 2022-09-01
Classification & Regulation
This clearance is catalogued under FDA product code NUH and 21 CFR 882.5890, within the Neurology review panel as a Class II device.