The Venous Assist System
The Venous Assist System, also called DVT-PRO, is an intermittent pneumatic compression system. Its powered pump sends air through a hose to cuffs worn on the calf or foot, applying…
The Venous Assist System, also called DVT-PRO, is an intermittent pneumatic compression system. Its powered pump sends air through a hose to cuffs worn on the calf or foot, applying external pressure to support venous circulation.
The main unit contains the air pump, electronic controls and an air distributor. For the three-chamber calf cuff, the distributor inflates the chambers in sequence and repeats the cycle for the selected treatment period.
Listed Item
Sequential compression pump only, The DVT-PRO device is a specialized intermittent pneumatic compression (IPC) system to prevent DVT (Deep Vein Thrombosis) and PE (Pulmonary Embolism) by improving the venous blood flow in at risk patients.
Cuffs and Controls
The calf cuff has three air chambers, while the foot cuff has one. Pressure is selected through the control panel, with different ranges for the calf and foot configurations. The system can operate from its power adaptor or rechargeable lithium-ion battery and is used for circulation support and deep vein thrombosis prophylaxis.
Who Else Makes It
Concentrated in Guangdong (10), Jiangsu (7), Zhejiang (4). 14 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo MPF Manufacturing Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 35 |
| JKH Health Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 22 |
| Jiangsu Reak Healthy Articles Co., Ltd. | Yangzhong | Jiangsu | Contract manufacturer | 18 |
| Ningbo Albert Novosino Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 17 |
| Shenzhen Homed Medical Device Co Ltd | Shenzhen | Guangdong | Contract manufacturer | 13 |
| Alleva Medical (D.G.) Ltd | Dongguan | Guangdong | Contract manufacturer | 13 |
| Xiamen Weiyou Intelligent Technology Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 9 |
| Suzhou Minhua Medical Equipment Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
| Grandway Technology (Shenzhen) Limited | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Shanghai Caremate Medical Device Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 6 |
| Dongguan Esino Manufacturing Service Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| MedHealth Medical Limited | Shenzhen | Guangdong | Contract manufacturer | 2 |
Showing 12 of 24. All 24 manufacturers in China registered for Sleeve, Limb, Compressible
Record
| Listed by | Daesung Maref Co., Ltd., South Korea |
|---|---|
| FDA product code | JOW |
| Device type | Sleeve, Limb, Compressible |
| Device class | Class 2 |
| Regulation | 21 CFR 870.5800 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K150980 |
| Record published | 2016-09-06 |
| Record revised | 2024-09-19 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Packaging | Box of 120, box of 20, pack of 8, box of 2, box of 50 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| DVT-PRO | In distribution | ||
| DS032 | 2 | In distribution | |
| DS500 | 2 | In distribution | |
| DVT-2600 | In distribution | ||
| DS026 | 2 | In distribution | |
| DVT-PRO | In distribution | ||
| DVT-2600 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Flexitouch Plus | Tactile Systems Technology Inc | 151 |
| Flexitouch | Tactile Systems Technology Inc | 138 |
| Sleeve, Limb, Compressible | Stryker Sustainability Solutions | 113 |
| Airos | Airos Medical Inc | 101 |
| Medline | Medline Industries, Inc. | 97 |
| Kendall SCD | Cardinal Health | 73 |
| Wright | Wright Therapy Products, Inc. | 72 |
| ACTitouch | Tactile Systems Technology Inc | 70 |
| Medline ReNewal | Medline Industries, Inc. | 65 |
| Koya Medical | Koya Medical, Inc. | 61 |
| Aircast | DJO, LLC | 60 |
| Hydroven | Huntleigh Healthcare Ltd. | 49 |
Showing 12 of 363. All products under Sleeve, Limb, Compressible
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K203353 | 2021-04-22 |
| K203417 | 2021-03-28 |
| K203016 | 2020-12-05 |
| K160180 | 2016-11-03 |
| K150980 | 2016-05-12 |
| K112677 | 2012-01-13 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.