OmniStand
Exerciser, non-measuring for stroke rehabilitation
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.
| 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
| 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 | 2023-09-01 |
| Record revised | 2023-10-11 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A000-509 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| THERA-Trainer balo | 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.