THERA-Trainer Tigo
The system is a therapeutic device for circular passive, assistive or active movement of the upper and lower extremities. The transition from passive to active therapy is seamless. The…
The system is a therapeutic device for circular passive, assistive or active movement of the upper and lower extremities. The transition from passive to active therapy is seamless. The system is used in a seated position, e.g. in a wheelchair or suitable therapy chair. The movement is managed by two drive units which differentiate in upper and lower extremities. The drive unit for lower extremities is limited in extent by the selected crank radius. The drive unit for upper extremities is limited to one crank radius. Both drive units are never moved simultaneously. The therapy drive units for leg and arm do drive a supportive accessory for legs (footrests) and arms (therapy grips, arm support or arm rest) in a circular motion. The different accessories are interchangeable by the operator. With the user interface the operator is able to select a training type (upper extremity or lower extremity training) which heads for related therapy drive unit. The medical device guarantees a non-slip and tilt resistant stand during the training preparation of the device as well as during the training. The device can be easily transported to different places of use or storage by means of castors and transport belt. The interfaces of the upper drive unit are designed in such a way that other accessory options are easy to attach. The requirements for the use of these accessories are derived from the degree of disability of the user. The training of the upper extremities should be possible as an option and does not have to be present as a matter of principle.
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 | Medica Medizintechnik Gmbh, Germany |
|---|---|
| FDA product code | BXB |
| Device type | Exerciser, Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 890.5380 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-08-28 |
| Record revised | 2025-08-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
| Distribution end date | 2025-08-27 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 04.XX.XX | In distribution | |
| 02.XX.XX | Withdrawn |
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.