Therafirm Singles®

Opaque Open-Toe Thigh High Singles 12 pk Dispenser 30-40 Black X-large

Registry build 21.09.26
21manufacturers in China registered for this device type
37catalogue numbers in this listing
1510(k) clearance

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 Therafirm Singles®
Listed by Knit-Rite, Inc., United States
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
Premarket notification Exempt
Record published 2018-12-31
Record revised 2020-07-07 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Over the counter Yes
Label carries lot or batch number
Packaging Box of 12, box of 6, pack of 12
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Therafirm Singles®
Catalogue number Size Status
T562E0405 In distribution
T560E0205 In distribution
T563E0430 In distribution
T560E0430 In distribution
T502E0205 In distribution
T505E0430 In distribution
T500E0205 In distribution
T563E0405 In distribution
T500E0230 In distribution
T500E0405 In distribution
T502E0405 In distribution
T505E0105 In distribution
T505E0330 In distribution
T560E0405 In distribution
T504E0330 In distribution
T504E0105 In distribution
T563E0205 In distribution
T562E0205 In distribution
T501E0105 In distribution
T563E0230 In distribution
T504E0130 In distribution
T501E0330 In distribution
T503E0405 In distribution
T501E0130 In distribution
T502E0430 In distribution
T504E0305 In distribution
T562E0230 In distribution
T503E0205 In distribution
T502E0230 In distribution
T562E0430 In distribution
T500E0430 In distribution
T505E0130 In distribution
T503E0430 In distribution
T501E0305 In distribution
T505E0305 In distribution
T560E0230 In distribution
T503E0230 In distribution

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
K091141 2009-07-24

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