THERA-Trainer Balo

THERA-Trainer balo is a standing aid with balance function, suitable for static-dynamic training of patients with limited standing capacity. Safe standing and balance are important…

Registry build 21.09.26

THERA-Trainer balo is a standing aid with balance function, suitable for static-dynamic training of patients with limited standing capacity. Safe standing and balance are important requirements for walking. THERA-Trainer balo offers patients a safe environment during training based on a stable frame that supports the patient at the hips and optionally at the knees to practice standing and balancing without any danger and fear of falling. A mechanical adjustment function makes it possible to switch from static to dynamic standing training. In dynamic, balancing training the frame relies on a set of springs that offer a dynamic resistance to upper body movement while still ensuring a safe environment preventing falls.

10manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Guangdong (6), Shanghai (1), Fujian (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code PKS
Manufacturer City Province Registered as Device types
Shanghai Joy Crown Industry Co., Ltd. Pu Dong New Area Shanghai Contract manufacturer 64
GaleMed (Xiamen) Co., Ltd. Xiamen Fujian Contract manufacturer 33
IPE Plastic & Hardware Industy, Ltd Dongguan Guangdong Contract manufacturer 15
Guangzhou Nuoning Medical Supplies Co., Ltd. Guangzhou Guangdong Contract manufacturer 62
Saferlife Products Co., Ltd. Guangzhou Guangdong Contract manufacturer 58
Ningbo Jenius Polymer SCI-Tech Co., Ltd. Yinzhou District, Ningbo Zhejiang Manufacturer 29
Hefei MT Medical Co., Ltd. Hefei Anhui Manufacturer 23
Foshan Fuzikon Medical Technology Co., Ltd. Foshan Guangdong Manufacturer 21
Foshan Suncare Medical Products Co Ltd Foshan Guangdong Contract manufacturer 20
Foshan Feiyang Medical Equipment Co., Ltd. Foshan Guangdong Manufacturer 18

Record

Regulatory record for THERA-Trainer balo
Listed by Medica Medizintechnik Gmbh, Germany
FDA product code PKS
Device type Exerciser, Non-Measuring For Stroke Rehabilitation
Device class Class 1
Regulation 21 CFR 890.5370
Establishment Manufacturer
Premarket notification Exempt
Record published 2023-10-23

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries serial number

Catalogue Numbers

Catalogue numbers for THERA-Trainer balo
Catalogue number Size Status
01.XX.XX In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
OmniStand Medica Medizintechnik Gmbh 1
THERA-Trainer coro Medica Medizintechnik Gmbh 1
EksoUE Ekso Bionics 1

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