Optiform TOE Caps / Silk Lining / Silk Pocket CCL2
OPTIFORM TOE CAPS / SILK LINING / SILK POCKET CCL2. A custom sewn device from a flat knit compression template in the form of a tube intended to tightly fit over and apply…
OPTIFORM TOE CAPS / SILK LINING / SILK POCKET CCL2. A custom sewn device from a flat knit compression template in the form of a tube intended to tightly fit over and apply compression/pressure (i.e., graduated or even-force) to a part of a limb, typically for the treatment/prevention of a disorder(s) of circulation [e.g., venous insufficiency, deep vein thrombosis (DVT)], to control scarring, and/or to manage lymphoedema; it is neither a strip/roll binder, glove, sock/stocking, nor tubular support bandage. It is typically made of cotton or synthetic elastic material (e.g., Lycra and Spandex); it does not include antimicrobial features. This is a reusable device.
Who Else Makes It
Concentrated in Zhejiang (27), Jiangsu (22), Guangdong (11). 17 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Principle & Will Biotech (Pinghu) Co., Ltd. | Pinghu | Zhejiang | Contract manufacturer | 39 |
| HongYu BioTech (ShenZhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 15 |
| Yangzhou Feiyali Sporting Goods Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 15 |
| Foshan Nanhai Plus Medical Co Ltd | Foshan | Guangdong | Contract manufacturer | 12 |
| Suzhou Dukangning Medical Products Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
| Zhejiang Cathaya Health Care Devices Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 8 |
| Cixi Cijia Handicraft Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 7 |
| Ocean Well Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 5 |
| Zhejiang Maizi Hosiery Technology Co., Ltd. | Yiwu | Zhejiang | Contract manufacturer | 5 |
| Jiangsu Huanyi Industrial Co., Ltd. | Suqian | Jiangsu | Contract manufacturer | 4 |
| Walt Technology Group Co., Ltd. | Haining | Zhejiang | Contract manufacturer | 3 |
Showing 12 of 76. All 76 manufacturers in China registered for Stocking, Medical Support (For General Medical Purposes)
Record
| Listed by | Sigvaris, Inc., United States |
|---|---|
| FDA product code | FQL |
| Device type | Stocking, Medical Support (For General Medical Purposes) |
| Device class | Class 1 |
| Regulation | 21 CFR 880.5780 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-12-20 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 358598 | Pressure, CCL2/23-32 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Solidea | Calzificio Pinelli SRL | 3,321 |
| Royal Flush | Royal Knit Inc. | 3,185 |
| Juzo Soft | Julius Zorn, Inc. | 2,305 |
| Ames Walker | Legs 4 Life, LLC | 1,853 |
| Juzo Dynamic | Julius Zorn, Inc. | 1,404 |
| 780 Eversheer | Sigvaris, Inc. | 845 |
| Ease® | Knit-Rite, Inc. | 799 |
| 840 Soft Opaque | Sigvaris, Inc. | 582 |
| 550 Secure | Sigvaris, Inc. | 576 |
| Super Sheath | Royal Knit Inc. | 569 |
| Juzo Naturally Sheer | Julius Zorn, Inc. | 450 |
| Royal Stretch | Royal Knit Inc. | 432 |
Showing 12 of 807. All products under Stocking, Medical Support (For General Medical Purposes)
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.