Skip to content

ActiveCare HomeCare ActiveCare+S.F.T

by Medical Compression System (D.B.N.) Ltd.

ActiveCare HomeCare ActiveCare+S.F.T (A502B-0002-01) is a sequential venous compression system inflator (FDA Class II; FDA product code JOW, Sleeve, Limb, Compressible) made by Medical Compression System (D.B.N.) Ltd., cleared under FDA 510(k) K151377 on 16 Jul 2015 (1 earlier submission) and listed in FDA GUDID since 4 Aug 2017 (UDI-DI 17290016525394), active as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number17290016525394 UDI-DI Date4 Aug 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK151377 Date16 Jul 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K151377 decided 16 Jul 2015 Active· +1 more in the status table
  • FDA GUDID UDI-DI 17290016525394 listed 4 Aug 2017 Listed

Recalls

1 recall · FDA

    • Terminated Z-0386-2012 FDA Unclassified (pre-2012) initiated 28 Aug 2011

    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. The firm found that an ActiveCare+S.F.T device might cease to work if connected to a non-MCS AC/DC adaptor with a higher nominal voltage. As specified in each product's User Manual the ActiveCare+S.

Timeline

4 dated events

  1. Cleared FDA 510(k) K060146
  2. Recall initiated FDA recalls Z-0386-2012
  3. Cleared FDA 510(k) K151377
  4. Listed FDA GUDID 17290016525394

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
ActiveCare
Generic name
Sequential venous compression system inflator
Model / Ref / Catalog
HomeCare ActiveCare+S.F.T, A502B-0002-01
Primary DI / UDI-DI
17290016525394
510(k) Number
FDA product code
JOW
GMDN term
Sequential venous compression system inflator
Device class
Class II
Regulation number
870.5800
GUDID distribution status
In Commercial Distribution

Related devices

Category: Sequential venous compression system inflator

Cleared under the same submission (K060146)

Cleared under the same submission (K151377)

and 8 more cleared under K151377

Similar devices in this category

Other devices filed under Sequential venous compression system inflator.

Other devices from Medical Compression System (D.B.N.) Ltd.

See all devices from Medical Compression System (D.B.N.) Ltd. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)