# K122640: Vpulse

- Pathway: 510(k) (Traditional)
- Applicant: Cothera, LLC
- Decided: Feb 22, 2013 after 177 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 K944567 (1995). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061866: Nanotherm,  Vascutherm and Prothermo Therapy Wraps, Thermotek, Inc. (2006) Summary page 3.

## Indications for use
The VPULSE is intended to function as an intermittent, external compression device in extremities to prevent and reduce complications of poor circulation. This includes: * deep vein thrombosis, * chronic venous insufficiency, * venous stasis ulcers, * post-mastectomy edema and chronic lymphedema, * reduction of edema associated with soft tissue injuries such as burns, postoperative edema, and ligament sprains, * localized cold thermal therapy for post-traumatic and post-surgical medical and/or surgical conditions) * Aids the blood flow back to the heart * Treat and assist healing of cutaneous ulceration (wounds), reduce wound healing time, enhance arterial circulation (blood flow), reduce compartmental pressures, reduce edema (swelling), reduce the need for anticoagulant (blood thinning) medications.

Source page: https://510kreport.com/device/K122640
Methodology: https://510kreport.com/methodology