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Data / Medical devices / Splint, Temporary Training

Splint, Temporary Training (IQM): 37 FDA-registered makers in 8 countries

37 establishments in 8 countries are registered with the FDA to make Splint, Temporary Training (product code IQM, Class 1, 21 CFR 890.3025). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 3 510(k) clearances under this code, the latest on July 21, 1977, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
IQM
Device class
1
Regulation
890.3025
Medical specialty
Physical Medicine

Makers by country

CountryMakers
China14
Taiwan9
United States6
India3
South Korea2
Costa Rica1
Germany1
Egypt1

Makers of Splint, Temporary Training

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
Atlantic Coast Creations, Ltd.Central Falls, RI, United StatesManufacturer0000api.fda.gov
BL Tech Co., Ltd.Chuncheon-si Gangwon, South KoreaManufacturer0000api.fda.gov
Breg, Inc.Carlsbad, CA, United StatesSpecification developer0000api.fda.gov
Buy Asia Enterprise LtdDongguan City Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Changzhou Well Lands Technology Co., Ltd.Changzhou Jiangsu, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Cixi Cijia Handicraft Co. LtdCixi Zhejiang, ChinaContract manufacturer0000api.fda.gov
Confortex, S.A.San Jose, Costa RicaManufacturer0000api.fda.gov
CR Uno Industrial Co. LtdTaichung City, Taiwan, TaiwanContract manufacturer, Manufacturer0000api.fda.gov
Dongguan Suscong Healthcare Co., Ltd.Dongguan Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Dongguan Vigor Textile Co.,LtdDongguan Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
E-Life International Co., LtdYonghe Dist., Taipei, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Eisenbacher Dentalwaren Ed GMBHWOERTH Bavaria, GermanyManufacturer0000api.fda.gov
Hengshui Xukang Medical Appliances Co., Ltd.Hengshui City Hebei, ChinaManufacturer0000api.fda.gov
Horsing Enterprises Co LtdTaichung, TaiwanContract manufacturer, Manufacturer0000api.fda.gov
I-Ming Sanitary Materials Co., Ltd.Changhua, TaiwanManufacturer0000api.fda.gov
Liven Sports MFG. (xiamen) Co., Ltd.XIAMEN Fujian, ChinaManufacturer0000api.fda.gov
Lords Mark Industries Ltd.Daman and Diu Dadra and Nagar Haveli, IndiaManufacturer0000api.fda.gov
Mammon International Corp.Taipei City, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Medical Materials And Equipment Manufacturing, Well Lands Enterprise Co., Ltd.Taichung City, TaiwanContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
MGRM Medicare Ltd.Khairatabad, Hyderabad Andhra Pradesh, IndiaManufacturer0000api.fda.gov
Miracle Medical IndustriesEl Obour City Al Qahirah, EgyptContract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Orthotech Rehabilitation Co., Ltd.Xiamen Fujian, ChinaExporter to the US, Manufacturer0000api.fda.gov
Paifu Comfort Industrial Co LtdTainan City, TaiwanContract manufacturer, Manufacturer0000api.fda.gov
Power Well Healthcare Technology Co., Ltd.Changhua County, TaiwanExporter to the US, Manufacturer0000api.fda.gov
SILIPOS Holding LLCNiagara Falls, NY, United StatesManufacturer0000api.fda.gov
South Canal Intl. Co., Ltd.Tainan City, TaiwanManufacturer0000api.fda.gov
Shanghai Leison Medical & Healthcare Products Co., LtdShanghai, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Shock Doctor, Inc.Costa Mesa, CA, United StatesSpecification developer0000api.fda.gov
Suzhou Kingstone Garments Co., Ltd.Suzhou Jiangsu, ChinaContract manufacturer0000api.fda.gov
T&L (jiaxing) Co., Ltd.JIAXING Zhejiang, ChinaManufacturer0000api.fda.gov
Tommie Copper IncMount Kisco, NY, United StatesSpecification developer0000api.fda.gov
Tynor Orthotics (P) Ltd.Mohali Punjab, IndiaManufacturer0000api.fda.gov
Thuasne, LLCBakersfield, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Woosam Medical Co., Ltd.Paju-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Xiamen Bosegrow Medical Equipment Co.,ltdXiamen Fujian, ChinaExporter to the US, Manufacturer0000api.fda.gov
Xiamen J-Brace Medical Equipment Co., Ltd.Xiamen Fujian, ChinaManufacturer0000api.fda.gov
Zhejiang Rehan Medical Manufacturing Co., Ltd.Jiaxing City Zhejiang, ChinaManufacturer0000api.fda.gov

Updated July 21, 1977. 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.