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510(k) K221654

medi pneumatic compression system (pcs)-genius (Model 652) by Medi USA, LP — Product Code JOW

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

Other clearances by Medi USA, LP

  • K183631 — medi pneumatic compression system (pcs) – brio (Model 651) (January 25, 2019)
  • K051324 — MEDI BUTLER (December 5, 2005)
  • K941926 — MEDI STRUMPF (June 15, 1994)

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  • K251466 — VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compressio (October 28, 2025)
  • K251446 — PlasmaFlow X Compression Sleeve Device (XPF0001) (September 17, 2025)
  • K251086 — PnueAira (PNCU-01) (August 18, 2025)
  • K250817 — Coretech Compression System (Coretech RHB3003) (August 8, 2025)
  • K241096 — Venera 608 Deep Vein Thrombosis (DVT) Prevention System (January 15, 2025)
  • K240499 — ARTAIRA Arterial Compression Device (AACD01) (October 11, 2024)
  • K241746 — UMED REPROCESSED AIRCAST VENAFLOW FOOT CUFF; UMED REPROCESSED KENDALL SCD EXPRES (October 4, 2024)