# K150806: PulseFlowDF

- Pathway: 510(k) (Traditional)
- Applicant: Pulseflow Technologies
- Decided: Dec 16, 2015 after 265 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: 2 generations back to K944567 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981311: Cowboy XV, Kci New Technologies, Inc. (1999) Summary page 4.

## Indications for use
The PulseFlowDF™ is designed to enhance blood circulation in the venules and arterioles in patients with diabetic foot ulcers of the lower extremities. PulseFlowDF is intended for patients in the home who would benefit from increased blood flow to: • Treat and assist healing of cutaneous ulceration (wounds) • Reduce wound healing time • Enhance arterial circulation (blood flow) • Prevent venous stasis (slowing of blood flow) • Reduce compartmental pressures • Reduce edema (swelling) • Reduce post-operative pain and swelling • Reduce the need for anticoagulant medications (medications that thin the blood) and • Prevent Deep Venous Thrombosis (DVT) (blood clots in the deep veins).

Source page: https://510kreport.com/device/K150806
Methodology: https://510kreport.com/methodology