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
| Country | Makers |
|---|---|
| China | 18 |
| United States | 14 |
| Taiwan | 8 |
| India | 2 |
| Guatemala | 2 |
| Canada | 2 |
| Mexico | 2 |
| Vietnam | 1 |
| Cambodia | 1 |
| Egypt | 1 |
| Dominican Republic | 1 |
| Germany | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Benik Corp. | Silverdale, WA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changzhou Major Medical Products Co., Ltd. | CHANGZHOU Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changzhou Meiguan Care Products Technology Co.,ltd. | Changzhou Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cixi Cijia Handicraft Co. Ltd | Cixi Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| College Park Industries | Warren, MI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Deroyal Industries, Inc. | Powell, TN, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Supercare Medical Products Co., Ltd | Dongguan Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dynamic Techno Medicals Private Limited | Coimbatore Tamil Nadu, India | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elastic Therapy, LLC | Asheboro, NC, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elite Orthopaedics, Inc. | South El Monte, CA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fillauer, LLC | Chattanooga, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fortune Company Ltd. | Huizhou Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Frogfish International Corp. | Taipei City, Taiwan | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fullerton Manufacturing Limited | Da Nang Bac Lieu, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Nuoning Medical Supplies Co.,ltd | Guangzhou Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guardmed Healthcare KH Co., Ltd. | Bati District Takeo, Cambodia | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guatemala Medical Manufacturing | Villa Canales Guatemala, Guatemala | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Weize Imp & Exp Co., Ltd | Hangzhou Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hengshui Gangsheng Medical Instruments Co., Ltd | Hengshui Hebei, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hengshui Runde Medical Instruments Co.,ltd | Hengshui City Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hospital Equipment MFG. Co. | NOIDA Uttar Pradesh, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hubei Yjt Intelligent Technology Group Co., Ltd. | Wuhan Hubei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huzhou Universal Glove Company Limited | Huzhou Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ideavillage Products Corp. | Wayne, NJ, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Irufa Industrial Group Co., Ltd. | Tainan City, Taiwan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiundar Industrial Co., Ltd. | SHULIN CITY Taipei, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| JKH Health Co., Ltd. | Dongguan Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kao Chen Enterprise Co., Ltd. | Taichung City, Taiwan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| L&R Usa Inc. | Milwaukee, WI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| La Pointique International Ltd. | Seattle, WA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Magway Trading Inc. | Markham Ontario, Canada | Foreign private label distributor, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medex Medical Supplies Ltd. | China Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtech Acuna S.A. De C.V. | Acuna Coahuila, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Metacare Industrial Ltd | Guangzhou Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Miracle Medical Industries | El Obour City Al Qahirah, Egypt | Contract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oppo Medical, Inc. | Seattle, WA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Optec Usa, Inc | San Pedro De Macoris, Dominican Republic | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Optec Usa, Inc. | Lawrenceville, GA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Otto Bock Healthcare Canada | BURLINGTON Ontario, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ortho and Surgical Products Enterprises S.A. | Villa Canales Guatemala, Guatemala | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcare GmbH | DUDERSTADT Lower Saxony, Germany | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paifu Comfort Industrial Co Ltd | Tainan City, Taiwan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Plus Meditech Co., Ltd. Plant 2 | Tainan City, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Professional Products, Inc. | Defuniak Spgs, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SEI Medical S.A. de C.V. | Juarez Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Bairunheng Technology Co., Ltd. | shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teh Lin Prosthetic & Orthopaedic, Inc. | Taipei, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Trend Medical, LLC | Bethlehem, PA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Unite Medical, LLC | Lithia Springs, GA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Welltex Sports Co., Ltd. | Taipei City, Taiwan | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yangzhou Aolikes Sports Goods Co., Ltd. | Yangzhou Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yangzhou Qiangjing Sports Products Co.,ltd | Yangzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yearstar Healthcare Technology Co.,ltd | JIANGYIN Jiangsu, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.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.