Economy Foam Heel Protector
Catalogue number HP301, listed by Primo Medical Group, Inc, United States, under Accessories, Traction. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (2), Hebei (1), Tianjin (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Alphay Medical Device Co., Ltd. | Nantong | Jiangsu | Contract manufacturer | 6 |
| Hengshui Jingkang Medical Device Co., Ltd. | Hengshui | Hebei | Manufacturer | 31 |
| Auckland Medical Polymer (Tianjin) Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 6 |
| Dongguan ZHI QI Handbag Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 6 |
| Optima Healthcare Inc. (GD) | Dongguan | Guangdong | Manufacturer | 3 |
Record
| Listed by | Primo Medical Group, Inc, United States |
|---|---|
| FDA product code | ILZ |
| Device type | Accessories, Traction |
| Device class | Class 1 |
| Regulation | 21 CFR 890.5925 |
| Establishment | Contract manufacturer, Contract steriliser, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2021-07-26 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number |
| Packaging | Pair of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HP301 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ISI | Instrument Specialists, Inc. | 70 |
| Bioseal Inc. | Bioseal | 7 |
| DeRoyal | Deroyal Industries, Inc. | 7 |
| Chattanooga | DJO, LLC | 4 |
| EVERYWAY4ALL | Everyway Medical Instruments Co., Ltd. | 4 |
| Convoluted (Eggcrate) Bed Overlay Pad | Primo Medical Group, Inc | 3 |
| iTrac | Pivotal Health Solutions | 2 |
| Traction Adapter | Hill-ROM, Inc. | 2 |
| Rolko | Rolko Kohlgrüber GmbH | 1 |
| Buck’s Traction with Foot Position & Heel Hole | Primo Medical Group, Inc | 1 |
| Buck’s Traction with Heel Hole | Primo Medical Group, Inc | 1 |
| Shoulder Traction | Primo Medical Group, Inc | 1 |
Showing 12 of 17. All products under Accessories, Traction
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.