# K133274: Vena Pro

- Pathway: 510(k) (Traditional)
- Applicant: Innovamed Health, LLC
- Decided: Feb 12, 2014 after 111 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: 4 generations back to K915638 (1992). 15 ancestors in all.
22 later devices descend from it; 7 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103187: Tripleplay-VT Vascular Therapy System, Wildcat Medical, Inc. (2011) Summary page 2.
- K061125: Dvtcare CA5, Doctors Orders (2006) Summary page 2.
- K023573: Wizair Compression System, Medical Compression Systems (Dbn), Ltd. (2002) Summary page 2.
- K022340: Travelair Portable Compression System, Dynamic Air, Inc. (2003) Summary page 2.
- K011318: Venodyne DVT Advantage Plus, Microtek Medical, Inc. (2001) Summary page 3.

## Most influential descendants
- K151189: Cirona 6300 Disposable Deep Vein Thrombosis (DVT) Prevention System (2015), 5 descendants of its own
- K160318: PlasmaFlow (2016), 4 descendants of its own
- K193020: VenaPro Vascular Therapy System (2019), 2 descendants of its own
- K142728: ActiveCare+SFT; ActiveCare+SFT HomeCare (ActiveCare+SFT-sub-category), ActiveCare+DTx ; ActiveCare+DTx HomeCare (ActiveCare+DTx-sub-category) (2014), 2 descendants of its own
- K203310: SyneCare 1000 Deep Vein Thrombosis Prevention Therapy System (2021), 1 descendant of its own

## Indications for use
The Vena Pro Vascular Therapy System, model VP-31 1l, is intended to be an easy to use portable system, prescribed by a physician, for use in the home or clinical setting to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions). This device can be used to: Aid in the prevention of DVT; Enhance blood circulation; Diminish post-operative pain and swelling; Reduce wound healing time; Aid in the treatment and healing of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs. The unit can also be used as an aid in the prophylaxis for DVT by persons expecting to be stationary for long periods of time.

Source page: https://510kreport.com/device/K133274
Methodology: https://510kreport.com/methodology