Clearance Summary
Air Compression Therapy Device, model HW6007 received FDA 510(k) clearance under submission number K210240, sponsored by Konliking Tech & Dev. Limited. 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 2021-02-22.
- Submission: K210240
- Applicant / Sponsor: Konliking Tech & Dev. Limited
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5650
- Decision date: 2021-02-22
Classification & Regulation
This clearance is catalogued under FDA product code IRP and 21 CFR 890.5650, within the Physical Medicine review panel as a Class II device.