# K214053: Amputee Garment for use with Lympha Press Optimal Plus

- Pathway: 510(k) (Traditional)
- Applicant: Mego Afek AC, Ltd.
- Decided: Apr 14, 2022 after 108 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 Amputee Garment for use with Lympha Press Optimal Plus 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 • Reduction of wound healing time • Reduction of pain and swelling after injury and surgery • The device may also be beneficial in the management of Lipoedema The device is intended for hospital, home and clinic use

Source page: https://510kreport.com/device/K214053
Methodology: https://510kreport.com/methodology