Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4, ACM-PLUS-A5, ACM-PLUS-A6)
FDA 510(k) clearance K243206 · decided 2025-02-19
Clearance details
- K-number
- K243206
- Device name
- Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4, ACM-PLUS-A5, ACM-PLUS-A6)
- Applicant
- Sichuan Qianli-Beoka Medical Technology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-10-01
- Decision date
- 2025-02-19
- Days to decision
- 141 days
- Clearance type
- Traditional
- Product code
- IRP
- Device class
- 2
- Regulation number
- 890.5650
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Chengdu, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.