# K103247: Vascucomp

- Pathway: 510(k) (Traditional)
- Applicant: Thermotek, Inc.
- Decided: Dec 10, 2010 after 37 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). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072666: Bioarterial Plus, Arterial Blood Flow Enhancement System, Bio Compression Systems, Inc. (2007) Summary page 1.
- K061866: Nanotherm,  Vascutherm and Prothermo Therapy Wraps, Thermotek, Inc. (2006) Summary page 1.
- K060220: PBS Model 701A Compression Therapy Device, Mego Afek (2006) Summary page 1.

## Indications for use
The VascuComp™ compression system in AI Mode is used as an adjunct therapy for patients with ischemic disease of the lower extremities, due to one or more of the following causes: * Minor Amputations * Angioplasty / Stent Failure * Arteriopathic Wounds * Graft Failure * Intermittent Claudication * Ischemia * Night Pain * Rest Pain * Small Vessel Disease * Ulcers * Decrease the risk of deep venous thrombosis (DVT). * 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. *Treatment of Venous disorders and dysfunction of the "muscle pump"

Source page: https://510kreport.com/device/K103247
Methodology: https://510kreport.com/methodology