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Data / Medical devices / Orthosis, Cervical-Thoracic, Rigid

Orthosis, Cervical-Thoracic, Rigid (IQF): 68 FDA-registered makers in 14 countries

68 establishments in 14 countries are registered with the FDA to make Orthosis, Cervical-Thoracic, Rigid (product code IQF, Class 1, 21 CFR 890.3490). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 7 510(k) clearances under this code, the latest on September 20, 1983, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Product code
IQF
Device class
1
Regulation
890.3490
Medical specialty
Physical Medicine

Makers by country

CountryMakers
China28
United States19
India5
Italy3
Mexico2
Germany2
Turkey2
Chile1
Taiwan1
Egypt1
Indonesia1
Dominican Republic1
Spain1
Switzerland1

Makers of Orthosis, Cervical-Thoracic, Rigid

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
Abletech Orthopedics CorporationNew Taipei City Taiwan, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
Aid United International Co., LimitedShanghai, ChinaExporter to the US, Manufacturer0000api.fda.gov
Allmay Bodywear (shenzhen) Co., LtdShenzhen Guangdong, ChinaContract manufacturer0000api.fda.gov
Ampcare, LLCFort Worth, TX, United StatesManufacturer0000api.fda.gov
Anji Spenq Industrial Co., Ltd.Huzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Anping Guardian Medical Equipment Co.,ltdHengshui Hebei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Apothecaries Sundries MFG Pvt LtdGURUGRAM Haryana, IndiaManufacturer, Repackager or relabeler0000api.fda.gov
Becker Orthopedic Appliance Co.Troy, MI, United StatesManufacturer0000api.fda.gov
Beijing Jinwei Kangda Medical Instrument Ltd.Langfang City Hebei, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Black Patent LLCCongers, NY, United StatesSpecification developer0000api.fda.gov
Blunding S.A.MACUL SANTIAGO Region Metropolitana, ChileManufacturer0000api.fda.gov
BiometerPlus USA, Inc.Fremont, CA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Calze G.T. SrlCASALOLDO Mantova, ItalyManufacturer0000api.fda.gov
Depuy Spine, Inc.Raynham, MA, United StatesSpecification developer0000api.fda.gov
DJ Orthopedics De Mexico, S.A. De C.V.TIJUANA Baja California, MexicoManufacturer, Repackager or relabeler0000api.fda.gov
Djo, LLCCarlsbad, CA, United StatesSpecification developer0000api.fda.gov
Dongguan Supercare Medical Products Co., LtdDongguan Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Dynamic Techno Medicals Private LimitedCoimbatore Tamil Nadu, IndiaContract manufacturer, Manufacturer0000api.fda.gov
Dongguan City Ruimi Gift Products Co LtdDongguan Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Dragon Medical Co.,LtdSuzhou City Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
E-Life International Co., LtdYonghe Dist., Taipei, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Emergency Products & Research, Inc.Kent, OH, United StatesManufacturer0000api.fda.gov
F.G.P. S.R.L.DOSSOBUONO Verona, ItalyContract manufacturer0000api.fda.gov
Flamor SRLSan Pietro Novara, ItalyManufacturer0000api.fda.gov
Guangzhou New Design Biotechnology Co., Ltd.Guangzhou Guangdong, ChinaManufacturer0000api.fda.gov
Greenwood Marketing LLCBrandenburg, KY, United StatesContract manufacturer0000api.fda.gov
Huzhou Junda Industry Co., Ltd.Anji Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Kaipeng Medical Tech Development Co.,ltdNingBo Zhejiang, ChinaManufacturer0000api.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
Medi Se And Co. KGBAYREUTH Bavaria, GermanyManufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
MGRM Medicare Ltd.Khairatabad, Hyderabad Andhra Pradesh, IndiaManufacturer0000api.fda.gov
Miracle Medical IndustriesEl Obour City Al Qahirah, EgyptContract manufacturer, Exporter to the US, Manufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Multi Garmen IndonesiaBOGOR Jawa Barat, IndonesiaContract manufacturer0000api.fda.gov
Ningbo Tianbo First Aid Product Co., Ltd.Ningbo Zhejiang, ChinaManufacturer0000api.fda.gov
Ningbo Bolishun Commodity Co., Ltd.Ningbo Zhejiang, ChinaManufacturer0000api.fda.gov
Optec Usa, IncSan Pedro De Macoris, Dominican RepublicManufacturer0000api.fda.gov
Optec Usa, Inc.Lawrenceville, GA, United StatesManufacturer0000api.fda.gov
Orliman SluLa Pobla de Vallbona Valencia(Province), SpainManufacturer0000api.fda.gov
Orthoservice AGChiasso Ticino, SwitzerlandManufacturer0000api.fda.gov
Orthotech Rehabilitation Co., Ltd.Xiamen Fujian, ChinaExporter to the US, Manufacturer0000api.fda.gov
Otto Bock Healthcare LPSalt Lake City, UT, United StatesSpecification developer0000api.fda.gov
Preferred Industries, Inc.Fort Lauderdale, FL, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Professional Products, Inc.Defuniak Spgs, FL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Shijiazhuang Runyi Medical Device Technology Co.,ltd.Shijiazhuang Hebei, ChinaManufacturer0000api.fda.gov
Spinal Technology, LLCWest Yarmouth, MA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
SPM Medicare Pvt, Ltd.NOIDA Uttar Pradesh, IndiaManufacturer0000api.fda.gov
Shanghai Leison Medical & Healthcare Products Co., LtdShanghai, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Spinal Systems, LLCLouisville, KY, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Taicang Bibliogem Sporting Products Co.,ltd.Taicang City Jiangsu, ChinaManufacturer0000api.fda.gov
Tianjin Tairuibosi Medical Appliance Co., Ltd.Tianjin, ChinaManufacturer0000api.fda.gov
Tiburon Medical EnterprisesSan Jacinto, CA, United StatesManufacturer0000api.fda.gov
Trulife, Inc.Bellingham, WA, United StatesManufacturer0000api.fda.gov
Vizor Ortopedi Medikal Urunleri Pazarlama Ithalat Ihracat Sanayi Ve Ticaret Ltd StiKUCUKCEKMECE Istanbul, TurkeyContract manufacturer, Manufacturer0000api.fda.gov
VQ OrthocareVista, CA, United StatesManufacturer0000api.fda.gov
Variteks Ortopedi Sanayi A.S.Catalca Istanbul, TurkeyContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
X-CEN-TEK GmbH & Co. KGWardenburg Lower Saxony, GermanyManufacturer0000api.fda.gov
Xiamen Twe Orthopedics Co., LtdXiamen Fujian, ChinaManufacturer0000api.fda.gov
Xiamen Benli Medical Technology Co., Ltd.Xiamen City Fujian, ChinaManufacturer0000api.fda.gov
Yangzhou Qionghua Sports Goods Co.,ltdYangzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Zhangjiagang Herui Medical Equipment Co.,ltd.ZhangJiaGang City Jiangsu, ChinaManufacturer0000api.fda.gov
Zhangjiagang New Fellow Med Co., Ltd.Zhangjiagang Jiangsu, ChinaManufacturer0000api.fda.gov
Zhangpu Ortholife Rehabilitation Co., LtdZhangzhou Fujian, ChinaManufacturer0000api.fda.gov
Zhangzhou Recaring Medical Instrument Co., LtdZhangzhou Fujian, ChinaManufacturer0000api.fda.gov
Zhejiang Lidesen Medical Instrument Co., LtdHangzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Zeffer Research & Assoc. S. A. de C. V.Ensenada Baja California, MexicoContract manufacturer, Manufacturer0000api.fda.gov
voss medical productsSan Antonio, TX, United StatesManufacturer0000api.fda.gov

Updated September 20, 1983. 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.