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ActiveCare+SFT; ActiveCare+SFT HomeCare, ActiveCare+DTx; ActiveCare+DTx HomeCare

FDA 510(k)

Class II (US FDA 510(k))

510(k) K151377

by Medical Compression System (Dbn) , Ltd.

Identifiers

510(k) Number
K151377 FDA 510(k)
FDA Product Code
JOW FDA 510(k)
Models / Variants
ActiveCare+SFT FDA 510(k)
ActiveCare+SFT HomeCare, ActiveCare+DTx FDA 510(k)
ActiveCare+DTx HomeCare FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.5800 FDA 510(k)
Regulation Number
870.5800 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The ActiveCare+SFT and ActiveCare+DTx are sleeve devices for compressible limbs, designed for cardiovascular applications. These devices are manufactured by Medical Compression System (Dbn), Ltd. and are available in HomeCare versions.

The devices are supplied as Class II medical devices with FDA 510(k) clearance under product code JOW. They are regulated under number 870.5800 and have multiple registration numbers. The devices are intended for use in cardiovascular settings, though specific sterility, single-use or reusable status, MRI safety, and storage information are not provided in the data.

Frequently asked questions

What are the ActiveCare+SFT and ActiveCare+DTx devices used for?

The ActiveCare+SFT and ActiveCare+DTx are sleeve devices specifically designed for compressible limbs, intended for use in cardiovascular applications. They are manufactured by Medical Compression System (Dbn), Ltd. and available in HomeCare versions.

What is the regulatory status of these devices?

These devices are Class II medical devices with FDA 510(k) clearance under product code JOW. They are regulated under number 870.5800 and have multiple registration numbers, though specific sterility, single-use or reusable status, MRI safety, and storage information are not provided in the data.

Are there different models of the ActiveCare+SFT and ActiveCare+DTx devices?

Yes, the devices are available in different models including ActiveCare+SFT, ActiveCare+SFT HomeCare, ActiveCare+DTx, and ActiveCare+DTx HomeCare, though specific size variations or model distinctions beyond these names are not detailed in the provided information.

Who manufactures these compression sleeve devices?

The ActiveCare+SFT and ActiveCare+DTx devices are manufactured by Medical Compression System (Dbn), Ltd., a company based in Or-Akiva, Israel. The manufacturer has multiple FEI numbers associated with these devices.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medical Compression System (Dbn) , Ltd.

Sources (1)

  • FDA 510(k) K151377 24 fields · synced Sep 21, 2026