# K110159: Activecare SFT

- Pathway: 510(k) (Traditional)
- Applicant: Medical Compression Systems (Dbn), Ltd.
- Decided: May 12, 2011 after 113 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 K944567 (1995). 10 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060146: Activecare ++ System, Medical Compression Systems (Dbn), Ltd. (2006) Summary page 1.

## Most influential descendants
- K140755: Activecare DVT, Activecare+SFT, and Activecare+DTX Systems (2014), 7 descendants of its own
- K162481: RF1400 Active Compression Wrap (2017), 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
- K232300: ElastiMed SACS (2023), 1 descendant of its own
- K151377: ActiveCare+SFT;ActiveCare+SFT HomeCare, ActiveCare+DTx;ActiveCare+DTx HomeCare (2015), 1 descendant of its own

## Indications for use
The ActiveCare+SFT® System is a prescriptive device that induces Continuous Enhanced Circulation Therapy of the lower limbs. The ActiveCare+SFT® System is intended for use in: * Preventing Deep Vein Thrombosis (DVT). * Enhancing blood circulation. * Diminishing post-operative pain and swelling. * Reducing wound-healing time. * Treatment and assistance in healing: stasis dermatitis; venous stasis ulcers; arterial and diabetic leg ulcers. * Treatment of chronic venous insufficiency. * Reducing edema.

Source page: https://510kreport.com/device/K110159
Methodology: https://510kreport.com/methodology