Cold Compression Wrap Pro
FDA 510(k) clearance K230524 · decided 2024-01-19
Clearance details
- K-number
- K230524
- Device name
- Cold Compression Wrap Pro
- Applicant
- Chengdu Cryo-Push Medical Technology Co.,Ltd
- Decision
- Substantially Equivalent
- Date received
- 2023-02-27
- Decision date
- 2024-01-19
- Days to decision
- 326 days
- Clearance type
- Traditional
- Product code
- IRP
- Device class
- 2
- Regulation number
- 890.5650
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Chengdu, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.