# K060146: Activecare ++ System

- Pathway: 510(k) (Traditional)
- Applicant: Medical Compression Systems (Dbn), Ltd.
- Decided: Mar 8, 2006 after 48 days
- Product code: JOW (Sleeve, Limb, Compressible)
- Device class: 2
- Regulation: 21 CFR 870.5800
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K944567 (1995). 9 ancestors in all.
30 later devices descend from it; 6 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023573: Wizair Compression System, Medical Compression Systems (Dbn), Ltd. (2002) Summary page 1.
- K012994: Wizair DVT, Medical Compression Systems (Dbn), Ltd. (2002) Summary page 3.
- K002287: Wizair Compression System, Medical Compression Systems (Dbn), Ltd. (2000) Summary page 1.
- K993758: Proair 3000 Compression System, Medical Compression Systems (Dbn), Ltd. (2000) Summary page 1.

## Most influential descendants
- K062818: Flexitouch System (2006), 10 descendants of its own
- K120972: Flexitouch System (2012), 9 descendants of its own
- K110159: Activecare SFT (2011), 9 descendants of its own
- K153311: Flexitouch System (2016), 8 descendants of its own
- K113525: Activecare DVT Activecare+SFT (2012), 8 descendants of its own

## Recalls of this device
- Aug 28, 2011 · Not classified · Z-0386-2012: This voluntary field action is being undertaken because MCS has received a limited number of reports involving the use of a non-MCS AC/DC adaptor with the ActiveCare DVT and ActiveCare+S.F.T. devices.

## Indications for use
The ActiveCare®++ System is a prescriptive device that induces Continuous Enhanced Circulation Therapy of the lower limbs. The ActiveCare®++ 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/K060146
Methodology: https://510kreport.com/methodology