EN-Dynamic Leg Extension
Catalogue number 1455955, listed by Enraf-Nonius B.V., Netherlands, under Exerciser, Powered. 27 manufacturers in China are registered for this product code.
27manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (6), Guangdong (6), Fujian (5). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou Nuoning Medical Supplies Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 62 |
| IPE Plastic & Hardware Industy, Ltd | Dongguan | Guangdong | Contract manufacturer | 15 |
| Ningbo Ningyuan Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 80 |
| Saferlife Products Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 58 |
| Xiamen Ortocare Sports Health Co., Ltd. | Xiamen Free Trade Zone | Fujian | Contract manufacturer | 32 |
| Jiangsu Rooe Medical Technology Co., Ltd. | Zhangjiagang | Jiangsu | Manufacturer | 31 |
| Shenzhen Eyco Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 27 |
| Xiamen J-Brace Medical Equipment Co., Ltd. | Xiamen | Fujian | Repacker / relabeller | 24 |
| Hangzhou Zhongzhi Industry Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 22 |
| Zhejiang Mateside Medical Devices Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 21 |
| Anhui Kangfu Industrial Foreign Trade Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 18 |
| Fuzhou Feiwo Trading Co., Ltd. | Fuzhou | Fujian | Manufacturer | 11 |
Showing 12 of 27. All 27 manufacturers in China registered for Exerciser, Powered
Record
| Listed by | Enraf-Nonius B.V., Netherlands |
|---|---|
| FDA product code | BXB |
| Device type | Exerciser, Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 890.5380 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2025-02-11 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment atmospheric pressure 50 to 106 KiloPascal; Handling environment humidity 10 to 90 % RH; Handling environment temperature 10 to 40 °C; Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment humidity 10 to 95 % RH; Storage environment temperature -10 to 50 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1455955 | In distribution |
Same Product Code
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|---|---|---|
| AlterG Anti-Gravity Treadmill | Lifeward CA, Inc. | 25 |
| Lokomat | Hocoma AG | 25 |
| APT Performer | Drive DeVilbiss Healthcare | 15 |
| Hand of Hope | Rehab-Robotics Company Limited | 14 |
| rebless | H Robotics Inc. | 10 |
| Medical HAL Lumbar Type | Cyberdyne Inc. | 9 |
| SwimEx Aquatherapy pool | SwimEx, Inc. | 8 |
| Chattanooga | DJO, LLC | 8 |
| RL-500 | Daesung Maref Co., Ltd. | 6 |
| THERA-Trainer toro | Medica Medizintechnik Gmbh | 6 |
| Handheld Direct Drive Cable Trainer | Beyond Power Inc. | 4 |
| MiraColt Generation 4 Seat | Chariot Innovations Inc | 4 |
Showing 12 of 91. All products under Exerciser, Powered
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.