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Data / Medical devices / Splint, Abduction, Congenital Hip Dislocation

Splint, Abduction, Congenital Hip Dislocation (IOZ): 30 FDA-registered makers in 9 countries

30 establishments in 9 countries are registered with the FDA to make Splint, Abduction, Congenital Hip Dislocation (product code IOZ, Class 1, 21 CFR 890.3665). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 4 510(k) clearances under this code, the latest on March 8, 1983, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
IOZ
Device class
1
Regulation
890.3665
Medical specialty
Physical Medicine

Makers by country

CountryMakers
United States12
China9
Mexico2
Turkey2
Netherlands1
Chile1
Vietnam1
Taiwan1
India1

Makers of Splint, Abduction, Congenital Hip Dislocation

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
Alex Orthopedic, Inc.Grand Prairie, TX, United StatesManufacturer0000api.fda.gov
Basko Healthcare B.V.ZAANDAM Noord-Holland, NetherlandsComplaint file establishment, Exporter to the US, Manufacturer0000api.fda.gov
Blunding S.A.MACUL SANTIAGO Region Metropolitana, ChileManufacturer0000api.fda.gov
Comfortland International, LLCMebane, NC, United StatesSpecification developer0000api.fda.gov
Deroyal Industries, Inc.Powell, TN, United StatesComplaint file establishment, Specification 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
Dongguan Vigor Textile Co.,LtdDongguan Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Fillauer, LLCChattanooga, TN, United StatesManufacturer0000api.fda.gov
Foundation Wellness International Co., LTD (FWIL)Binh Duong, VietnamManufacturer0000api.fda.gov
Hangzhou Weize Imp & Exp Co., LtdHangzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Hengshui Gangsheng Medical Instruments Co., LtdHengshui Hebei, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Innovative Medical Products, Inc.Plainville, CT, United StatesSpecification developer0000api.fda.gov
Jiundar Industrial Co., Ltd.SHULIN CITY Taipei, TaiwanExporter to the US, Manufacturer0000api.fda.gov
M/S. Ascent Meditech LimitedGOREGAON (E) Maharashtra, IndiaManufacturer0000api.fda.gov
Orthomerica Products, Inc.Orlando, FL, United StatesManufacturer0000api.fda.gov
Restorative Care Of America, Inc.Saint Petersburg, FL, United StatesManufacturer0000api.fda.gov
Span-America Medical Systems, Inc.Greenville, SC, United StatesContract manufacturer0000api.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
Variteks Ortopedi Sanayi A.S.Catalca Istanbul, TurkeyContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Wheaton Brace CompanyCarol Stream, IL, United StatesSpecification developer0000api.fda.gov
Yangzhou Jindu Sporting Goods Co., Ltd.Yangzhou Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Zhangpu Ortholife Rehabilitation Co., LtdZhangzhou Fujian, ChinaManufacturer0000api.fda.gov
Zhangzhou Recaring Medical Instrument Co., LtdZhangzhou Fujian, ChinaManufacturer0000api.fda.gov
Zeffer Research & Assoc. S. A. de C. V.Ensenada Baja California, MexicoContract manufacturer, Manufacturer0000api.fda.gov
Zhejiang Rehan Medical Manufacturing Co., Ltd.Jiaxing City Zhejiang, ChinaManufacturer0000api.fda.gov

Updated March 8, 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.