Clearance Summary
Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100, MINI-TENS-COMB, RC101I, TENS3500) received FDA 510(k) clearance under submission number K231423, 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 2024-01-22.
- Submission: K231423
- 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: 2024-01-22
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.