510(k) K221654
K221654 is an FDA 510(k) premarket notification submitted by Medi USA, LP for the device "medi pneumatic compression system (pcs)-genius (Model 652)". The FDA issued a decision of Substantially Equivalent on July 7, 2022. The device falls under product code JOW (Sleeve, Limb, Compressible), a Class II device regulated under 21 CFR 870.5800. Medi USA, LP has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 7, 2022
- Date Received
- June 7, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Sleeve, Limb, Compressible
- Device Class
- Class II
- Regulation Number
- 870.5800
- Review Panel
- CV
- Submission Type