# K191937: Ezvena IPC, Ezvena SQS

- Pathway: 510(k) (Traditional)
- Applicant: Eezcare Medical Corp
- Decided: Jan 29, 2020 after 194 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 K890938 (1989). 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)
- K143438: Flowtron ACS900, Getinge (Suzhou) Co., Ltd. (2015) Summary page 4.

## Indications for use
To apply intermittent pneumatic compression to the lower limbs to help prevent deep vein thrombosis.

Source page: https://510kreport.com/device/K191937
Methodology: https://510kreport.com/methodology