# K061866: Nanotherm,  Vascutherm and Prothermo Therapy Wraps

- Pathway: 510(k) (Traditional)
- Applicant: Thermotek, Inc.
- Decided: Aug 22, 2006 after 50 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). 7 ancestors in all.
52 later devices descend from it; 9 cite it directly.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942796: Presssion S Iii, Chattanooga Group, Inc. (1995) Summary page 1.
- K981311: Cowboy XV, Kci New Technologies, Inc. (1999) Summary page 1.
- K023800: Venaflow Reusable Calf Aircell, Model 3018, Venaflow Disposable Calf Cover, Model 3017, Aircast, Inc. (2003) Summary page 1.
- K043423: Model SC-3008 Sequential Circulator, Bio Compression Systems, Inc. (2005) Summary page 1.
- K011318: Venodyne DVT Advantage Plus, Microtek Medical, Inc. (2001) Summary page 1.
- K964799: Artrotherm Cryotherapy and Thernotherapy, Ormed GmbH (1997) Summary page 1.

## Most influential descendants
- K103187: Tripleplay-VT Vascular Therapy System (2011), 25 descendants of its own
- K133274: Vena Pro (2014), 22 descendants of its own
- K171685: Med4 Elite (2017), 21 descendants of its own
- K181149: Therm-X Pro, Therm-X AT, Therm-X Pro Athlete (2018), 12 descendants of its own
- K190854: Therm-X (2019), 11 descendants of its own

## Indications for use
Treatment of disorders associated with vascular or lymphatic insufficiency such as Chronic Venous Insufficiency (CVI), 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 thermal therapy (hot or cold) for post traumatic and post surgical medical and/or surgical conditions. Treatment of disorders associated with vascular or lymphatic insufficiency such as Chronic Venous Insufficiency (CVI), venous stasis ulcers, post-mastectomy edema and chronic lymphedema. Reduction of edema associated with soft tissue injuries such as bums, postoperative edema, and ligament sprains. Localized thermal therapy (hot or cold) for post traumatic and post surgical medical and/or surgical conditions. 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 would 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/K061866
Methodology: https://510kreport.com/methodology