YY-A02-B Overlapped Compression Therapy
FDA 510(k) clearance K221862 · decided 2022-12-08
Clearance details
- K-number
- K221862
- Device name
- YY-A02-B Overlapped Compression Therapy
- Applicant
- Huizhou Xinyi Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2022-06-27
- Decision date
- 2022-12-08
- Days to decision
- 164 days
- Clearance type
- Traditional
- Product code
- IRP
- Device class
- 2
- Regulation number
- 890.5650
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Huizhou, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.