510(k) clearance
Air compression massager (ACM-C1, ACM-C2, ACM-C3, ACM-C4, ACM-C5, ACM-C6, ACM-C7, ACM-C8, ACM-C9, ACM-5C1, ACM-5C2, ACM-5C3, ACM-5C4, ACM-5C5, ACM-5C6, ACM-5C7, ACM-5C8, ACM-5C9)
- 510(k) number
- K262812
- Applicant
- Sichuan Qianli-Beoka Medical Technology, Inc.
- Decision date
- Oct 5, 2026
- Date received
- Aug 7, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- IRP
- Device type
- Massager, Powered Inflatable Tube
- Device class
- Class II
- Regulation
- 21 CFR 890.5650
- Advisory committee
- Physical Medicine
- Statement or summary
- Summary
- Third party
- N
- Location
- Chengdu, CN