Hole IN TOE Sheath ®
Hole IN TOE Sheath White Rgsh Size 1&2 10-14" Length
21manufacturers in China registered for this device type
2catalogue 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.
| 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
| 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
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2HPBRHSH | In distribution | |
| 2HPWRHSH | In distribution |
Same 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
| 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.