# K160178: Lympha-Flow (LF1200)

- Pathway: 510(k) (Special)
- Applicant: Daesung Maref Co., Ltd.
- Decided: Jan 11, 2017 after 350 days
- Product code: IRP (Massager, Powered Inflatable Tube)
- Device class: 2
- Regulation: 21 CFR 890.5650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K914774 (1992). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102320: Compressible Limb and Circulation Therapy System Model LX7(V7), Daesung Maref Co., Ltd. (2011) Summary page 5.

## Indications for use
Lympha-Flow(LF1200) is intended for use by medical professionals and patients at home, who are under medical supervision, in treating many conditions, such as : Primary lymphedema, Edema following trauma and sport injuries, Postimmobilization edema, Venous insufficiencies, Lymphedema.

Source page: https://510kreport.com/device/K160178
Methodology: https://510kreport.com/methodology