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…

Registry build 21.09.26

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.

27manufacturers in China registered for this device type
2catalogue numbers in this listing

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.

Chinese manufacturers registered for FDA product code BXB
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

Regulatory record for THERA-Trainer tigo
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

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries serial number
Distribution end date 2025-08-27

Catalogue Numbers

Catalogue numbers for THERA-Trainer tigo
Catalogue number Size Status
04.XX.XX In distribution
02.XX.XX Withdrawn

Same Product Code

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Product Sold by Catalogue numbers
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Hand of Hope Rehab-Robotics Company Limited 14
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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
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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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer