Data / Medical devices / Exerciser, Non-Measuring For Stroke Rehabilitation
Exerciser, Non-Measuring For Stroke Rehabilitation (PKS): 17 FDA-registered makers in 5 countries
17 establishments in 5 countries are registered with the FDA to make Exerciser, Non-Measuring For Stroke Rehabilitation (product code PKS, Class 1, 21 CFR 890.5370). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 0 recall events (0 Class I). FDA data exported November 3, 2026.
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- Product code
- PKS
- Device class
- 1
- Regulation
- 890.5370
- Medical specialty
- Physical Medicine
Makers by country
| Country | Makers |
|---|---|
| China | 8 |
| United States | 5 |
| Israel | 2 |
| South Korea | 1 |
| Germany | 1 |
Makers of Exerciser, Non-Measuring For Stroke Rehabilitation
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Accelerated Care Plus Corp. | Reno, NV, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bo&bo Ltd | Amir Northern, Israel | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bodypoint Designs, Inc. | Seattle, WA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bioxtreme Ltd. | Petach Tikva Central, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Foshan Feiyang Medical Equipment Co., Ltd. | Foshan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Foshan Suncare Medical Products Co Ltd | Foshan City Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Foshan Fuzikon Medical Technology Co.Ltd | Foshan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Nuoning Medical Supplies Co.,ltd | Guangzhou Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GaleMed (Xiamen) Co., Ltd. | XIAMEN Fujian, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hefei MT Medical Co.,ltd. | Hefei Anhui, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| IPE Plastic & Hardware Industy, LTD | Dongguan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Man & Company Limited | Gumi-Si Gyeongbuk, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medica Medizintechnik GMBH | HOCHDORF Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mirrored Motion Works Inc | Durham, NC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Neuro Rehab Recovery Inc | Belleair, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Resola | Idaho Falls, ID, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Joy Crown Industry Co., Ltd | Pu Dong New Area Shanghai, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.