# K203310: SyneCare 1000 Deep Vein Thrombosis Prevention Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Synecoun Medical Technology Co., Ltd.
- Decided: Apr 2, 2021 after 143 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: 5 generations back to K915638 (1992). 16 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133274: Vena Pro, Innovamed Health, LLC (2014) Summary page 4.

## Most influential descendants
- K211937: SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System (2021), 0 descendants of its own

## Indications for use
The Synecare 1000 deep vein thrombosis preve11tion system is intended to be an easy to use portable system, prescribed by a physician, to help prevent the onset ofDVT in patients by stimulating blood flow in the extremities (simulating muscle contractions). This device can be used in the home or clinical settings to: •Aid in the prevention ofDVT • Enhance blood circulation •Diminish post-operative pain and swelling • Reduce wound healing time •Aid in the treatment of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs •As a prophylaxis forDVT by persons expecting to be stationary for long periods of time

Source page: https://510kreport.com/device/K203310
Methodology: https://510kreport.com/methodology