# K121962: Practical Compression Device (PCD) 901A&901B

- Pathway: 510(k) (Traditional)
- Applicant: Mego Afek AC, Ltd.
- Decided: Oct 19, 2012 after 106 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Primary lymphedlema Secondary lymphedema Venous insufficiency Venous stasis ulcers Dysfunction of the muscle pump The device is intended to be used by patient at home, as well as by physicians at clinic.

Source page: https://510kreport.com/device/K121962
Methodology: https://510kreport.com/methodology