510(k) K253064
Air Pressure Therapy System (VU-IPC8M); Air Pressure Therapy System (VU-IPC6M); Air Pressure Therapy System (VU-IPC4X) by
Xiamen Weiyou Intelligent Technology Co., Ltd.
— Product Code IRP
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 30, 2026
- Date Received
- September 22, 2025
- 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