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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

CountryMakers
China4
India2
United Kingdom2
United States2
Hong Kong1
Vietnam1
Egypt1
Taiwan1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Apothecaries Sundries MFG Pvt LtdGURUGRAM Haryana, IndiaManufacturer, Repackager or relabeler0000api.fda.gov
Changzhou Meiguan Care Products Technology Co.,ltd.Changzhou Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Dongguan Nan You Sporting Goods Enterprise LtdDongguan Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Gyrogear LimitedBerkhamsted Hertfordshire, United KingdomManufacturer0000api.fda.gov
Hengshui Gangsheng Medical Instruments Co., LtdHengshui Hebei, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Hospital Equipment MFG. Co.NOIDA Uttar Pradesh, IndiaManufacturer0000api.fda.gov
J&C Supply-Chains Trade LimitedHk, Hong KongManufacturer0000api.fda.gov
Liang Cheng Sporting Goods Company LimitedBen Cat Ward Ho Chi Minh, VietnamContract manufacturer, Manufacturer0000api.fda.gov
Miracle Medical IndustriesEl Obour City Al Qahirah, EgyptContract manufacturer, Exporter to the US, Manufacturer, Remanufacturer0000api.fda.gov
Open BionicsBristol Bristol, City of, United KingdomManufacturer0000api.fda.gov
RCM Enterprise LLCOlympia, WA, United StatesManufacturer0000api.fda.gov
Relief MedicalPhoenix, AZ, United StatesSpecification developer0000api.fda.gov
Tien Jiang Enterprise Co., Ltd.Tainan City, TaiwanContract manufacturer, Manufacturer0000api.fda.gov
Zhongshan Chukuang Textile Co., Ltd.Zhongshan City, Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.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.