Cold/Hot Compression
FDA 510(k) clearance K223541 · decided 2023-10-27
Clearance details
- K-number
- K223541
- Device name
- Cold/Hot Compression
- Applicant
- Jkh Health Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2022-11-25
- Decision date
- 2023-10-27
- Days to decision
- 336 days
- Clearance type
- Traditional
- Product code
- IRP
- Device class
- 2
- Regulation number
- 890.5650
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Shenzhen, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.