Clearance Summary
Combo Electrotherapy Device received FDA 510(k) clearance under submission number K192087, sponsored by Shenzhen Roundwhale Technology Co. , 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 2019-11-01.
- Submission: K192087
- Applicant / Sponsor: Shenzhen Roundwhale Technology Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 2019-11-01
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.