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) K262812
Substantially EquivalentSichuan Qianli-Beoka Medical Technology, Inc.
FDA 510(k) clearance K262812 for 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), Substantially Equivalent on 2026-10-05. Applicant: Sichuan Qianli-Beoka Medical Technology, Inc.. Device class: 2.
Summary
Sichuan Qianli-Beoka Medical Technology's air compression massager is cleared in 18 models, ACM-C1 through ACM-C9 and ACM-5C1 through ACM-5C9. Product code IRP is powered inflatable tube massagers.
Class II, 21 CFR 890.5650. The Physical Medicine panel reviewed it as a Traditional 510(k).
The company filed from Chengdu, China. Review took 59 days (August 7 to October 5, 2026).
Clearance details
- Applicant
- Sichuan Qianli-Beoka Medical Technology, Inc.
- Product code
- Product code IRP
- Device class
- Class 2
- Regulation
- 21 CFR 890.5650
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chengdu, CN
Recent devices under product code IRP
view allMore clearances from Sichuan Qianli-Beoka Medical Technology, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.