VenoTrain Curaflow

VenoTrain Curaflow compression garments apply controlled pressure to the extremities for management of lymphoedema, other oedematous conditions, phlebitis and vascular disorders. Their…

Registry build 21.09.26

VenoTrain Curaflow compression garments apply controlled pressure to the extremities for management of lymphoedema, other oedematous conditions, phlebitis and vascular disorders. Their pressure helps limit pooling of blood and fluid in the covered limb.

The garments are flat-knitted from nylon and spandex yarns and sewn together. Elastic yarns act around the circumference of the extremity to provide the intended compression rather than using a powered pump or inflatable chamber.

Garment Construction

The sewn, flat-knit fabric provides the compressive structure. Its function is sustained external pressure on the extremity as part of the prescribed management of swelling or vascular conditions.

21manufacturers in China registered for this device type
3catalogue numbers in this listing
2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Zhejiang (9), Jiangsu (5), Hunan (2). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code DWL
Manufacturer City Province Registered as Device types
Viecura Medical Group Limited Suzhou Jiangsu Contract manufacturer 9
Shaoxing Haoshide Medical Products Co., Ltd. Shaoxing Zhejiang Contract manufacturer 7
Walt Technology Group Co., Ltd. Haining Zhejiang Contract manufacturer 3
Yiwu Maitu Trading Co., Ltd. Jinhua Zhejiang Contract manufacturer 3
Zhejiang Jasan Holding Group Jiangshan Knitting Co., Ltd. Jiangshan Zhejiang Contract manufacturer 2
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Jiangsu NEW Pentastar Medical Products Co., Ltd. Changzhou Jiangsu Exporter 146
Hubei Qianjiang Kingphar Medical Material Co., Ltd. Qianjiang Hubei Contract manufacturer 52
Hengshui Gangsheng Medical Instruments Co., Ltd. Hengshui Hebei Contract manufacturer 36
Suzhou Shangchuang Technology Service Co., Ltd. Suzhou Jiangsu Manufacturer 23
Cofoe Medical Technology Co., Ltd. Changsha Hunan Contract manufacturer 22
Hangzhou Zhongzhi Industry Co., Ltd. Hangzhou Zhejiang Manufacturer 22

Showing 12 of 21. All 21 manufacturers in China registered for Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)

Record

Regulatory record for VenoTrain curaflow
Listed by Bauerfeind AG, Germany
FDA product code DWL
Device type Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
Device class Class 2
Regulation 21 CFR 880.5780
Establishment Manufacturer
510(k) K111662
Record published 2016-10-06
Record revised 2020-07-07 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Label carries serial number
Distribution end date 2016-10-07

Catalogue Numbers

Catalogue numbers for VenoTrain curaflow
Catalogue number Size Status
20000009900008 In distribution
20000009900002 Withdrawn
20000009900001 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
VenoTrain micro Bauerfeind AG 25,529
VenoTrain soft Bauerfeind AG 16,217
Medi Medi Manufacturing Inc 12,972
Jobst Elvarex BSN-Jobst Gmbh 9,318
VenoTrain soft S Bauerfeind AG 7,091
VenoTrain impuls Bauerfeind AG 2,480
Truform® Surgical Appliance Industries, Inc. 2,324
Jobst Confidence BSN-Jobst Gmbh 1,801
VenoTrain micro balance Bauerfeind AG 1,596
Jobst Custom Seamless Soft BSN-Jobst Gmbh 1,454
Jobst forMen BSN Medical, Inc. 1,344
Jobst Elvarex Soft BSN-Jobst Gmbh 1,311

Showing 12 of 130. All products under Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K111662 2011-10-04
K860826 1986-06-18

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer