Devon 24R DVT Prevention Therapy System
by Devon Medical Products (Jiangsu), Ltd. 510(k)
Active
510(k) K173528
Overview
The Devon 24R DVT Prevention Therapy System is a Sleeve, Limb, Compressible device designed to prevent deep vein thrombosis (DVT) by mechanically stimulating blood flow in the extremities. It operates through rhythmic compression to simulate muscle contractions, reducing the risk of clot formation in patients at risk for DVT.
This system is intended for use in clinical settings and is supplied as a reusable device. It is classified under FDA regulation 870.5800 and received FDA 510(k) clearance (K173528) as substantially equivalent to a predicate device. The system is intended for cardiovascular applications and is regulated under Class II medical devices.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK173528 | Date6 Feb 2018 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- Devon 24R Deep Vein Thrombosis (DVT) Prevention Therapy System
- 510(k) Number
- FDA Product Code
- JOW
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.5800
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent