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Data / Medical devices / Joint, Shoulder, External Limb Component

Joint, Shoulder, External Limb Component (IQQ): 53 FDA-registered makers in 12 countries

53 establishments in 12 countries are registered with the FDA to make Joint, Shoulder, External Limb Component (product code IQQ, 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
IQQ
Device class
1
Regulation
890.3420
Medical specialty
Physical Medicine

Makers by country

CountryMakers
China18
United States14
Taiwan8
India2
Guatemala2
Canada2
Mexico2
Vietnam1
Cambodia1
Egypt1
Dominican Republic1
Germany1

Makers of Joint, Shoulder, External Limb Component

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
Benik Corp.Silverdale, WA, United StatesManufacturer0000api.fda.gov
Changzhou Major Medical Products Co., Ltd.CHANGZHOU Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Changzhou Meiguan Care Products Technology Co.,ltd.Changzhou Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Cixi Cijia Handicraft Co. LtdCixi Zhejiang, ChinaContract manufacturer0000api.fda.gov
College Park IndustriesWarren, MI, United StatesManufacturer0000api.fda.gov
Deroyal Industries, Inc.Powell, TN, United StatesComplaint file establishment, Specification 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
Elastic Therapy, LLCAsheboro, NC, United StatesSpecification developer0000api.fda.gov
Elite Orthopaedics, Inc.South El Monte, CA, United StatesManufacturer, Specification developer0000api.fda.gov
Fillauer, LLCChattanooga, TN, United StatesManufacturer0000api.fda.gov
Fortune Company Ltd.Huizhou Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Frogfish International Corp.Taipei City, TaiwanExporter to the US, Specification developer0000api.fda.gov
Fullerton Manufacturing LimitedDa Nang Bac Lieu, VietnamManufacturer0000api.fda.gov
Guangzhou Nuoning Medical Supplies Co.,ltdGuangzhou Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Guardmed Healthcare KH Co., Ltd.Bati District Takeo, CambodiaExporter to the US, Manufacturer0000api.fda.gov
Guatemala Medical ManufacturingVilla Canales Guatemala, GuatemalaContract manufacturer0000api.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
Hengshui Runde Medical Instruments Co.,ltdHengshui City Hebei, ChinaManufacturer0000api.fda.gov
Hospital Equipment MFG. Co.NOIDA Uttar Pradesh, IndiaManufacturer0000api.fda.gov
Hubei Yjt Intelligent Technology Group Co., Ltd.Wuhan Hubei, ChinaManufacturer0000api.fda.gov
Huzhou Universal Glove Company LimitedHuzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Ideavillage Products Corp.Wayne, NJ, United StatesSpecification developer0000api.fda.gov
Irufa Industrial Group Co., Ltd.Tainan City, TaiwanContract manufacturer, Manufacturer0000api.fda.gov
Jiundar Industrial Co., Ltd.SHULIN CITY Taipei, TaiwanExporter to the US, Manufacturer0000api.fda.gov
JKH Health Co., Ltd.Dongguan Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Kao Chen Enterprise Co., Ltd.Taichung City, TaiwanContract manufacturer, Manufacturer0000api.fda.gov
L&R Usa Inc.Milwaukee, WI, United StatesSpecification developer0000api.fda.gov
La Pointique International Ltd.Seattle, WA, United StatesSpecification developer0000api.fda.gov
Magway Trading Inc.Markham Ontario, CanadaForeign private label distributor, Specification developer0000api.fda.gov
Medex Medical Supplies Ltd.China Guangdong, ChinaManufacturer0000api.fda.gov
Medtech Acuna S.A. De C.V.Acuna Coahuila, MexicoContract manufacturer0000api.fda.gov
Metacare Industrial LtdGuangzhou Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Miracle Medical IndustriesEl Obour City Al Qahirah, EgyptContract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Oppo Medical, Inc.Seattle, WA, United StatesSpecification developer0000api.fda.gov
Optec Usa, IncSan Pedro De Macoris, Dominican RepublicManufacturer0000api.fda.gov
Optec Usa, Inc.Lawrenceville, GA, United StatesManufacturer0000api.fda.gov
Otto Bock Healthcare CanadaBURLINGTON Ontario, CanadaManufacturer0000api.fda.gov
Ortho and Surgical Products Enterprises S.A.Villa Canales Guatemala, GuatemalaContract manufacturer0000api.fda.gov
Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcare GmbHDUDERSTADT Lower Saxony, GermanyManufacturer, Specification developer0000api.fda.gov
Paifu Comfort Industrial Co LtdTainan City, TaiwanContract manufacturer, Manufacturer0000api.fda.gov
Plus Meditech Co., Ltd. Plant 2Tainan City, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Professional Products, Inc.Defuniak Spgs, FL, United StatesManufacturer0000api.fda.gov
SEI Medical S.A. de C.V.Juarez Chihuahua, MexicoContract manufacturer0000api.fda.gov
Shenzhen Bairunheng Technology Co., Ltd.shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Teh Lin Prosthetic & Orthopaedic, Inc.Taipei, TaiwanManufacturer0000api.fda.gov
Trend Medical, LLCBethlehem, PA, United StatesSpecification developer0000api.fda.gov
Unite Medical, LLCLithia Springs, GA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Welltex Sports Co., Ltd.Taipei City, TaiwanExporter to the US, Specification developer0000api.fda.gov
Yangzhou Aolikes Sports Goods Co., Ltd.Yangzhou Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Yangzhou Qiangjing Sports Products Co.,ltdYangzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Yearstar Healthcare Technology Co.,ltdJIANGYIN Jiangsu, 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.