# K232640: Venowave VW5

- Pathway: 510(k) (Special)
- Applicant: Thermabright
- Decided: Jun 25, 2024 after 305 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 K944567 (1995). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073028: Venowave Models VW5-6, VW5-10, VW5-20 and VW5-30, Venowave, Inc. (2008) Summary page 4.

## Indications for use
The Venowave VW5 series of devices are prescriptive and induce improved vascular and lymphatic flow of the lower limbs. Venowave device are intended to treat the following: Indications for Use: • Management of the symptoms of post thrombolytic syndrome (PTS) • Prevention of deep vein thrombosis (DVT) • Prevention of primary thrombosis • Treatment of lymphedema • Diminishing post-operative pain and swelling • Treatment of leg swelling due to vascular insufficiency • Treatment of varicose veins • Treatment of chronic venous insufficiency • Enhancing blood circulation • Treatment of intermittent claudication

Source page: https://510kreport.com/device/K232640
Methodology: https://510kreport.com/methodology