Simulator II
A rehabilitation device for upper extremity strength testing and exercise. The dynamometer offers isometric and concentric isotonic modes, as well as many adapters for isolated joint and…
A rehabilitation device for upper extremity strength testing and exercise. The dynamometer offers isometric and concentric isotonic modes, as well as many adapters for isolated joint and compound motions.
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 | BTE Technologies, United States |
|---|---|
| FDA product code | BXB |
| Device type | Exerciser, Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 890.5380 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K800007 |
| Record published | 2016-08-25 |
| Record revised | 2020-05-08 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Sim II 03 | In distribution | |
| Sim II 5 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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.