Medi
***disc*manumed Active Wrist Left Sand X
4manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (2), Hebei (1), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou Nuoning Medical Supplies Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Dongguan Supercare Medical Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 41 |
| Hengshui Gangsheng Medical Instruments Co., Ltd. | Hengshui | Hebei | Contract manufacturer | 36 |
| Huzhou Universal Glove Company Limited | Huzhou | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Medi Manufacturing Inc |
|---|---|
| FDA product code | ISZ |
| Device type | Unit, Wrist, External Limb Component, Mechanical |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3420 |
| Premarket notification | Exempt |
| Record published | 2019-02-11 |
| Record revised | 2026-02-09 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | manufacturing date |
| Distribution end date | 2020-04-20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 64281 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Wrist | Hugh Steeper Ltd | 37 |
| Taska Lamination Collar Kit (6-band), 45mm, Black | Taska Prosthetics | 1 |
| Explorer Twin Module LRG with spacer | macu4 GmbH | 1 |
| Explorer Pinch Module spacer | macu4 GmbH | 1 |
| Taska Seal Ring Kit, 50mm, Black | Taska Prosthetics | 1 |
| Explorer Hold Lock Module | macu4 GmbH | 1 |
| Explorer Bike Module STD with spacer | macu4 GmbH | 1 |
| Explorer Ball Module STD with spacer | macu4 GmbH | 1 |
| Explorer Ring STD | macu4 GmbH | 1 |
| Explorer Twin Module STD with spacer | macu4 GmbH | 1 |
| Low Profile Lamination Kit, CX, 50mm | Taska Prosthetics | 1 |
| Explorer Swim Module SML without spacer | macu4 GmbH | 1 |
Showing 12 of 35. All products under Unit, Wrist, External Limb Component, Mechanical
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.