510(k) K243206
Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4, ACM-PLUS-A5, ACM-PLUS-A6) by
Sichuan Qianli-Beoka Medical Technology, Inc.
— Product Code IRP
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 19, 2025
- Date Received
- October 1, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Massager, Powered Inflatable Tube
- Device Class
- Class II
- Regulation Number
- 890.5650
- Review Panel
- PM
- Submission Type