Coolflex Boot XL/XXL Reg LT Black (Bulk)
Catalogue number 20418 or 360700, listed by Sigvaris, Inc., United States, under Binder, Medical, Therapeutic. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo MPF Manufacturing Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 35 |
| Jiangsu Xinbei Electrical Appliances Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 6 |
Record
| Listed by | Sigvaris, Inc., United States |
|---|---|
| FDA product code | MDR |
| Device type | Binder, Medical, Therapeutic |
| Device class | Class 1 |
| Regulation | 21 CFR 880.5160 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-08-11 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 20418 or 360700 | Pressure, Variable mmHg | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medi | Medi Manufacturing Inc | 752 |
| Solidea | Calzificio Pinelli SRL | 129 |
| 12 MedaFit | Sigvaris, Inc. | 126 |
| Juzo Compression Wrap | Julius Zorn, Inc. | 117 |
| CompreFLEX | Sigvaris, Inc. | 82 |
| 11 CompreFit | Sigvaris, Inc. | 78 |
| 21 CoolFlex | Sigvaris, Inc. | 56 |
| 14 CompreFlex Arm | Sigvaris, Inc. | 44 |
| Jobst Bella | BSN Medical, Inc. | 32 |
| Bella Lite Glove | BSN Medical, Inc. | 32 |
| Juzo Custom Compression Garments | Julius Zorn, Inc. | 29 |
| 14 CompreFlex Knee | Sigvaris, Inc. | 28 |
Showing 12 of 355. All products under Binder, Medical, Therapeutic
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.