# K172277: Phlebo Press DVT Model

- Pathway: 510(k) (Traditional)
- Applicant: Mego Afek AC, Ltd.
- Decided: Nov 3, 2017 after 98 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
The Phlebo Press DVT Model 760D including compression garments is intended for use by healthcare professionals, and patients who are under medical supervision, in treating conditions such as: • 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 • Reducing edema • Treatment of chronic venous insufficiency The device is intended for hospital, home and clinic use

Source page: https://510kreport.com/device/K172277
Methodology: https://510kreport.com/methodology