# K203746: Venen-trainer (Model: FM150, SFM90)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Pango Electronic Co., Ltd.
- Decided: Nov 10, 2021 after 323 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
Longest line of descent: 3 generations back to K043423 (2005). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210417: Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL, Bio Compression Systems, Inc. (2021). Cleared while this submission was under review Summary page 4.

## Indications for use
Venen-trainer (Model: FM150, SFM90) is intended for either primary or adjunctive treatment of lymphedema, peripheral edema, lipedema, venous insufficiency, and venous stasis ulcers. These devices are also intended for the prophylaxis of deep vein thrombosis (DVT). Intended for use in a home or healthcare setting.

Source page: https://510kreport.com/device/K203746
Methodology: https://510kreport.com/methodology