# K221654: medi pneumatic compression system (pcs)-genius (Model 652)

- Pathway: 510(k) (Traditional)
- Applicant: Medi USA, LP
- Decided: Jul 7, 2022 after 30 days
- Product code: JOW (Sleeve, Limb, Compressible)
- Device class: 2
- Regulation: 21 CFR 870.5800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K043423 (2005). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183631: medi pneumatic compression system (pcs) – brio (Model 651), Medi USA, LP (2019) Summary page 4.

## Indications for use
The medi pneumatic compression system (pcs) genius is a compression device based on sequential pneumatic compression technique which is intended for the treatment of the following conditions: -Lymphedema -Venous stasis ulcers -Venous insufficiency -Peripheral edema The device is intended for home, and hospital use.

Source page: https://510kreport.com/device/K221654
Methodology: https://510kreport.com/methodology