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Data / Medical devices / Sling, Arm, Overhead Supported

Sling, Arm, Overhead Supported (ILE): 63 FDA-registered makers in 14 countries

63 establishments in 14 countries are registered with the FDA to make Sling, Arm, Overhead Supported (product code ILE, Class 1, 21 CFR 890.3475). 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 April 5, 1983, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
ILE
Device class
1
Regulation
890.3475
Medical specialty
Physical Medicine

Makers by country

CountryMakers
China26
United States10
Taiwan8
India4
Germany3
Vietnam3
Denmark2
Mexico1
Ukraine1
Egypt1
Indonesia1
Spain1
Sri Lanka1
Cambodia1

Makers of Sling, Arm, Overhead Supported

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
Breg, Inc.Carlsbad, CA, United StatesSpecification developer0000api.fda.gov
BSN Medical GmbHHamburg, GermanyComplaint 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 Nan You Sporting Goods Enterprise LtdDongguan Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Dongguan Redthera Technology Co., Ltd.Dongguan Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Dynamic Techno Medicals Private LimitedCoimbatore Tamil Nadu, IndiaContract manufacturer, Manufacturer0000api.fda.gov
Dongguan SafeSecure Plastics Co., Ltd.Dongguan City Guangdong, ChinaContract 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
Etac A/SGedved Midtjylland, DenmarkManufacturer0000api.fda.gov
Fortune Company Ltd.Huizhou Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Guldmann-Ukraine LtdLviv L'vivs'ka Oblast', UkraineManufacturer0000api.fda.gov
Guangdong Hexin Technology Weaving Co., LTDHuizhou City Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Hengshui Tianjian Medical Supplies Co., Ltd.ShenZhou City Hebei, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Heptex Industry Company LimitedViet Tri Phu Tho, VietnamExporter to the US, Manufacturer0000api.fda.gov
Home Medical Products Inc.Taichung City, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Inovi Healthcare, LLCOwings Mills, MD, United StatesSpecification developer0000api.fda.gov
Jiangsu Moen Industrial Co.,ltdSuqian Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Kao Chen Enterprise Co., Ltd.Taichung City, TaiwanContract manufacturer0000api.fda.gov
Le Shin International Co., Ltd.Kaohsiung,, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Liang Cheng Sporting Goods Company LimitedBen Cat Ward Ho Chi Minh, VietnamContract manufacturer, Manufacturer0000api.fda.gov
Lifeline First Aid LLCLake Oswego, OR, United StatesRepackager or relabeler, Specification developer0000api.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
Medex Medical Supplies Ltd.China Guangdong, ChinaManufacturer0000api.fda.gov
Miracle Medical IndustriesEl Obour City Al Qahirah, EgyptContract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Multi Garmen IndonesiaBOGOR Jawa Barat, IndonesiaContract manufacturer0000api.fda.gov
Ningbo Favored Commodity Co.,ltdNINGBO Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Ningbo MPF Manufacturing Co.,ltd.Ningbo Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
NYOrthoBrooklyn, NY, United StatesManufacturer0000api.fda.gov
Orthomerica Products, Inc.Orlando, FL, United StatesManufacturer0000api.fda.gov
Orthotech Rehabilitation Co., Ltd.Xiamen Fujian, ChinaExporter to the US, Manufacturer0000api.fda.gov
Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcare GmbHDUDERSTADT Lower Saxony, GermanyManufacturer, Specification developer0000api.fda.gov
Preferred Industries, Inc.Fort Lauderdale, FL, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Prim,s.a.Mostoles Madrid(Province), SpainManufacturer0000api.fda.gov
R&R Medical Corporation Ltd.Sanchong District New Taipei, TaiwanManufacturer0000api.fda.gov
Refirmance Athletic Protector Co., Ltd.Taichung, TaiwanManufacturer0000api.fda.gov
Rhino Consultants And FacilitatorsWattala Gampaha, Sri LankaManufacturer0000api.fda.gov
Safesecure Medical Packaging Company LimitedHai Phong City, VietnamContract manufacturer0000api.fda.gov
Shenzhen Weprotex Technology Product Co.,ltdShenzhen Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Special Protectors Co., Ltd.New Taipei City, TaiwanManufacturer0000api.fda.gov
SPM Medicare Pvt, Ltd.NOIDA Uttar Pradesh, IndiaManufacturer0000api.fda.gov
STREIFENEDER ortho.production gmbHEMMERING Bavaria, GermanyExporter to the US, Manufacturer0000api.fda.gov
Shenzhen SafeSecure Medical Infection Control Tech Co., LtdShenzhen City Guangdong, ChinaExporter to the US, Specification developer0000api.fda.gov
Taicang Yigao Medical Technology Co.,ltdTaicang Jiangsu, ChinaManufacturer0000api.fda.gov
Tien Jiang Enterprise Co., Ltd.Tainan City, TaiwanContract manufacturer, Manufacturer0000api.fda.gov
Trend Medical, LLCBethlehem, PA, United StatesSpecification developer0000api.fda.gov
Tynor Orthotics (P) Ltd.Mohali Punjab, IndiaManufacturer0000api.fda.gov
V. Guldmann A/SAARHUS N Midtjylland, DenmarkManufacturer0000api.fda.gov
VIVE Health LLCNaples, FL, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Wellpower Sporting Goods Co., Ltd.Dong Guan Guangdong, ChinaManufacturer0000api.fda.gov
WP Sports (cambodia) Co., Ltd.Bavet City Svay Rieng, CambodiaManufacturer0000api.fda.gov
Xiamen Ortocare Sports Health Co.,ltd.Xiamen Free Trade Zone Fujian, ChinaContract manufacturer0000api.fda.gov
Xiamen Twe Orthopedics Co., LtdXiamen Fujian, ChinaManufacturer0000api.fda.gov
Xtreme Orthopedics, LLC D/B/A FlexxlineFayetteville, AR, United StatesSpecification developer0000api.fda.gov
Yangzhou Zhilin Sports Items Co., LtdYangzhou Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Yearstar Healthcare Technology Co.,ltdJIANGYIN 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

Updated April 5, 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.