# K140642: PCD 737A

- Pathway: 510(k) (Traditional)
- Applicant: Mego Afek AC, Ltd.
- Decided: Jun 10, 2014 after 90 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. The FDA summary names no predicate by number.

## Indications for use
PCD 737A is intended for use by medical professionals, and patients who are under medical supervision, in treating many conditions such as: * Primary lymphedema * Secondary lymphedema * Venous insufficiency * Venous stasis ulcers * Dysfunction of the muscle pump * Post mastectomy edema * Edema following trauma and sports issues * Post immobilization edema * Reducing wound healing time * Prevention of deep vein thrombosis (DVT) in patients who may be susceptible * Reduction of pain and swelling after injury and surgery * Enhancement Of venous circulation * Prevention of venous stasis * Assistance in healing of cutaneous ulcers * Reduction of compartmental pressures The device is intended for hospital, home, and clinic use.

Source page: https://510kreport.com/device/K140642
Methodology: https://510kreport.com/methodology