Clearance Summary
Air Compression Massager (ACM-A1, ACM-A2, ACM-A3, ACM-A4) received FDA 510(k) clearance under submission number K241446, sponsored by Sichuan Qianii-Beoka Medical Technoiogy Lnc.. 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 2024-10-08.
- Submission: K241446
- Applicant / Sponsor: Sichuan Qianii-Beoka Medical Technoiogy Lnc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5650
- Decision date: 2024-10-08
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.