MedHealth DVT Compression Devices MHH900S/MHH900E
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K231801 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 MedHealth DVT Compression Devices MHH900S/MHH900E are Sleeve, Limb, Compressible, designed to prevent or treat deep vein thrombosis (DVT) by applying graduated compression to the lower limbs. These devices are classified as Class II medical devices and are intended for sequential pneumatic compression therapy to improve venous return and reduce the risk of clot formation in patients at risk for DVT or those recovering from surgery.
These devices are supplied as single-use, non-sterile sleeves for application to the calf or thigh. They are regulated under the FDA 510(k) pathway, Medical Device Directive (MDD), and Medical Device Regulation (MDR), with a Traditional 510(k) clearance (K231801) and FDA decision code SESE. Compatible with standard pneumatic compression therapy systems, they are intended for use in clinical, hospital, or home settings where venous circulation support is required. No MRI safety information is specified.
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 (2 countries)
Regulatory Authorizations
MDR
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K231801 | Class II | Active |
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Manufacturer
- Manufacturer
- MedHealth Medical Limited
Sources (2)
- FDA 510(k) K231801 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026