Intermittent pressure compression system (Compression Pump PT1005A; Leg Compression Cuffs; L-1001S, L-1001L, L-1001XL, L-1001XXL, L-1001XXXL)
FDA 510(k) clearance K242615 · decided 2025-07-23
Clearance details
- K-number
- K242615
- Device name
- Intermittent pressure compression system (Compression Pump PT1005A; Leg Compression Cuffs; L-1001S, L-1001L, L-1001XL, L-1001XXL, L-1001XXXL)
- Applicant
- Xiamen Taotao Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2024-09-03
- Decision date
- 2025-07-23
- Days to decision
- 323 days
- Clearance type
- Traditional
- Product code
- IRP
- Device class
- 2
- Regulation number
- 890.5650
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Xiamen City, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.