Hot and Cold Compression System (A02-C-032)
FDA 510(k) clearance K252386 · decided 2026-04-03
Clearance details
- K-number
- K252386
- Device name
- Hot and Cold Compression System (A02-C-032)
- Applicant
- Chengdu Cryo-Push Medical Technology Co.,Ltd
- Decision
- Substantially Equivalent
- Date received
- 2025-07-31
- Decision date
- 2026-04-03
- Days to decision
- 246 days
- Clearance type
- Traditional
- Product code
- IRP
- Device class
- 2
- Regulation number
- 890.5650
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- 611137, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.