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ActiveCare Foot sleeve Pair

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

ActiveCare Foot sleeve Pair (A201F-1280-10) 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 and listed in FDA GUDID since 5 Jan 2018 (UDI-DI 07290016525519), active as of 23 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K151377

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07290016525519 UDI-DI Date5 Jan 2018ListedStatusListed 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
  • FDA GUDID UDI-DI 07290016525519 listed 5 Jan 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K151377
  2. Listed FDA GUDID 07290016525519

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  • Withdrawn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
ActiveCare Foot sleeve Pair, A201F-1280-10
Primary DI / UDI-DI
07290016525519
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 (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

  • Single use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)