Air compression leg massager HY-1117A
FDA 510(k) clearance K212713 · decided 2022-01-18
Clearance details
- K-number
- K212713
- Device name
- Air compression leg massager HY-1117A
- Applicant
- Xiamen High Top Electronic Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2021-08-26
- Decision date
- 2022-01-18
- Days to decision
- 145 days
- Clearance type
- Traditional
- Product code
- IRP
- Device class
- 2
- Regulation number
- 890.5650
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Xiamen, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.