ActiveCare+SFT +2 more— 510(k) K142728

Name: FDA 510(k) clearance K142728
Creator: U.S. Food and Drug Administration
Published: 2014-12-04

Substantially Equivalent

Medical Compressions System (Dbn) , Ltd.

FDA 510(k) clearance K142728 for ActiveCare+SFT +2 more, Substantially Equivalent on 2014-12-04. Applicant: Medical Compressions System (Dbn) , Ltd.. Device class: 2.

Clearance details

Device name as filed: ActiveCare+SFT; ActiveCare+SFT HomeCare (ActiveCare+SFT-sub-category), ActiveCare+DTx ; ActiveCare+DTx HomeCare (ActiveCare+DTx-sub-category)
Applicant: Medical Compressions System (Dbn) , Ltd.
Product code: Code JOW
Device class: Class 2
Regulation: 21 CFR 870.5800
Advisory panel: Cardiovascular
Date received: 2014-09-23
Decision date: 2014-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Or Akiva, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code JOW

view all

K261807 — Sequential Circulator (SC-4004-DL, SC-4008-DL)2026-09-11
K254217 — Aerloom2026-08-31
K253555 — Flexitouch® Plus Advanced Pneumatic Compression System2026-07-31
K253386 — DVT Garment2026-06-25
K250242 — Compression Therapy Device (LGT-2202DVT)2026-04-24

Data sourced from openFDA. This site is unofficial and independent of the FDA.