510(k) K242615
Intermittent pressure compression system (Compression Pump PT1005A; Leg Compression Cuffs; L-1001S, L-1001L, L-1001XL, L-1001XXL, L-1001XXXL) by
Xiamen Taotao Technology Co., Ltd.
— Product Code IRP
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 23, 2025
- Date Received
- September 3, 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