Data / Medical devices / Assembly, Shoulder/Elbow/Forearm/Wrist/Hand, Mechanical
Assembly, Shoulder/Elbow/Forearm/Wrist/Hand, Mechanical (KFT): 14 FDA-registered makers in 8 countries
14 establishments in 8 countries are registered with the FDA to make Assembly, Shoulder/Elbow/Forearm/Wrist/Hand, Mechanical (product code KFT, Class 1, 21 CFR 890.3420). 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 2, 2026.
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- Product code
- KFT
- Device class
- 1
- Regulation
- 890.3420
- Medical specialty
- Physical Medicine
Makers by country
| Country | Makers |
|---|---|
| China | 4 |
| India | 2 |
| United Kingdom | 2 |
| United States | 2 |
| Hong Kong | 1 |
| Vietnam | 1 |
| Egypt | 1 |
| Taiwan | 1 |
Makers of Assembly, Shoulder/Elbow/Forearm/Wrist/Hand, Mechanical
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 |
|---|---|---|---|---|---|---|---|---|
| Apothecaries Sundries MFG Pvt Ltd | GURUGRAM Haryana, India | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changzhou Meiguan Care Products Technology Co.,ltd. | Changzhou Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Nan You Sporting Goods Enterprise Ltd | Dongguan Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gyrogear Limited | Berkhamsted Hertfordshire, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hengshui Gangsheng Medical Instruments Co., Ltd | Hengshui Hebei, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hospital Equipment MFG. Co. | NOIDA Uttar Pradesh, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| J&C Supply-Chains Trade Limited | Hk, Hong Kong | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Liang Cheng Sporting Goods Company Limited | Ben Cat Ward Ho Chi Minh, Vietnam | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Miracle Medical Industries | El Obour City Al Qahirah, Egypt | Contract manufacturer, Exporter to the US, Manufacturer, Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Open Bionics | Bristol Bristol, City of, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RCM Enterprise LLC | Olympia, WA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Relief Medical | Phoenix, AZ, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tien Jiang Enterprise Co., Ltd. | Tainan City, Taiwan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhongshan Chukuang Textile Co., Ltd. | Zhongshan City, Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.