medi pneumatic compression system (pcs)-genius (Model 652)
FDA 510(k) clearance K221654 · decided 2022-07-07
Clearance details
- K-number
- K221654
- Device name
- medi pneumatic compression system (pcs)-genius (Model 652)
- Applicant
- Medi USA, LP
- Decision
- Substantially Equivalent
- Date received
- 2022-06-07
- Decision date
- 2022-07-07
- Days to decision
- 30 days
- Clearance type
- Traditional
- Product code
- JOW
- Device class
- 2
- Regulation number
- 870.5800
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Whitsett, NC, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.