DVT-Series
NON-WOVEN THIGH SLEEVE (Small [DS011] 2ea, Medium [DS012] 2ea, Large [DS013] 2ea, X-Large [DS014] 2ea) NON-WOVEN CALF SLEEVE (Small [DS021] 2ea, Medium [DS022] 2ea, Large [DS023] 2ea,…
NON-WOVEN THIGH SLEEVE (Small [DS011] 2ea, Medium [DS012] 2ea, Large [DS013] 2ea, X-Large [DS014] 2ea) NON-WOVEN CALF SLEEVE (Small [DS021] 2ea, Medium [DS022] 2ea, Large [DS023] 2ea, X-Large [DS024] 2ea) NON-WOVEN BOOT SLEEVE (Medium [DS041] 2ea) NON-WOVEN FOOT SLEEVE (Medium [DS031] 2ea)
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) | K203016 |
| Record published | 2021-06-22 |
| Record revised | 2023-03-09 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Packaging | Box of 20, box of 40, box of 10, box of 5, box of 80, box of 15 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DS222 | In distribution | |
| DS241 | In distribution | |
| DVTREUSET | In distribution | |
| DS300 | In distribution | |
| DS031 | In distribution | |
| DS011 | In distribution | |
| DS031 | In distribution | |
| DS223 | In distribution | |
| DS014 | In distribution | |
| DS012 | In distribution | |
| DS021 | In distribution | |
| DS041 | In distribution | |
| DS024 | In distribution | |
| DS221 | In distribution | |
| DVTNWSET | In distribution | |
| DS111 | In distribution | |
| DS033 | In distribution | |
| DS212 | In distribution | |
| DS131 | In distribution | |
| DS033 | In distribution | |
| DS121 | In distribution | |
| DS213 | In distribution | |
| DS301 | In distribution | |
| DS224 | In distribution | |
| DS023 | In distribution | |
| DS022 | In distribution | |
| DS214 | In distribution | |
| DS211 | In distribution | |
| DS141 | In distribution | |
| DS302 | In distribution | |
| DS013 | In distribution | |
| DVTSOFTSET | 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.