Clearance Summary
Combo Electrotherapy Device received FDA 510(k) clearance under submission number K231440, sponsored by Shenzhen Roundwhale Technology Co. , 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 2023-11-03.
- Submission: K231440
- Applicant / Sponsor: Shenzhen Roundwhale Technology Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5850
- Decision date: 2023-11-03
Classification & Regulation
This clearance is catalogued under FDA product code IPF and 21 CFR 890.5850, within the Physical Medicine review panel as a Class II device.