Activecare DVT, Activecare+SFT, and Activecare+DTX Systems
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K140755 FDA 510(k)
- FDA Product Code
- JOW 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 DVT, ActiveCare+SFT, and ActiveCare+DTX Systems are prescriptive devices that induce Continuous Enhanced Circulation Therapy of the lower limbs. They are intended for use in preventing Deep Vein Thrombosis (DVT).
These systems are supplied as external compression devices designed to work in synchrony with the patient's natural venous blood flow return profile to achieve high pulsatile venous blood flow. They are regulated under FDA 510(k) clearance (K140755) and classified as Class II devices under regulation number 870.5800, with product code JOW.
Frequently asked questions
What is the ActiveCare DVT, ActiveCare+SFT, and ActiveCare+DTX Systems used for?
These systems are prescriptive devices intended for preventing Deep Vein Thrombosis (DVT) by inducing Continuous Enhanced Circulation Therapy in the lower limbs. They work in synchrony with the patient's natural venous blood flow to achieve high pulsatile venous blood flow return, which helps reduce stasis and clot formation risk.
How are the ActiveCare DVT, ActiveCare+SFT, and ActiveCare+DTX Systems supplied and what is their use pattern?
The systems are supplied as external compression devices designed for use with the patient's natural venous blood flow return profile. They are prescriptive, meaning they require a healthcare provider's order, and are intended for continuous or intermittent use during periods of immobility to support circulation and prevent DVT.
Are the ActiveCare DVT, ActiveCare+SFT, and ActiveCare+DTX Systems reusable or single-use?
The device data does not specify whether the ActiveCare systems are reusable or single-use. As external compression devices intended for prescriptive use in DVT prevention, they may involve reusable components with disposable garments, but no explicit statement on reusability or disposability is provided in the source information.
What sizes or models are available for the ActiveCare DVT, ActiveCare+SFT, and ActiveCare+DTX Systems?
The device data lists multiple system names—ActiveCare DVT, ActiveCare+SFT, and ActiveCare+DTX—but does not provide specific sizes, dimensions, or model variations within these systems. No further details on sizing options or accessory configurations are included in the provided specifications.
What regulatory pathway was used for the ActiveCare DVT, ActiveCare+SFT, and ActiveCare+DTX Systems?
The systems were cleared through the FDA 510(k) pathway under submission number K140755. They are classified as Class II medical devices under regulation number 870.5800 with product code JOW, indicating they were found substantially equivalent to a predicate device.
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. Sources consulted: Activecare Dvt, Activecare+Sft, and Activecare+Dtx Systems, PDF ActiveCare Operations and Service Manual, ACTIVECARE SFT by MEDICAL COMPRESSION SYSTEMS (DBN) LTD. | FDA 510(k ..., ActiveCare+SFT; ActiveCare+SFT HomeCare (ActiveCare+SFT-sub-category ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K140755 | Class II | Active |
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Manufacturer
- Manufacturer
- Medical Compression Systems (Dbn) , Ltd.
Sources (1)
- FDA 510(k) K140755 24 fields · synced Sep 24, 2026