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Data / Medical devices / Cover, Limb

Cover, Limb (IPM): 119 FDA-registered makers in 24 countries

119 establishments in 24 countries are registered with the FDA to make Cover, Limb (product code IPM, Class 1, 21 CFR 890.3025). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 6 510(k) clearances under this code, the latest on September 21, 1987, and lists 1 recall event (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
IPM
Device class
1
Regulation
890.3025
Medical specialty
Physical Medicine

Makers by country

CountryMakers
United States45
China22
Mexico9
United Kingdom5
Vietnam4
Taiwan4
Germany4
Tunisia3
India3
Canada3
Turkey2
Spain2
Guatemala2
Lithuania1
Netherlands1
Dominican Republic1
Sweden1
Honduras1
Egypt1
Brazil1
Iceland1
Austria1
Bulgaria1
Switzerland1

Makers of Cover, Limb

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
AB Ortopedijos TechnikaKaunas Kauno Apskritis, LithuaniaContract manufacturer0000api.fda.gov
Acode Sporting Goods Company LimitedHo Chi Minh, VietnamExporter to the US, Manufacturer0000api.fda.gov
Advance Medical Designs, Inc.Marietta, GA, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Alps South LLCSaint Petersburg, FL, United StatesManufacturer0000api.fda.gov
Anji Hongde Medical Products Co., Ltd.HUZHOU Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Anji Sanfang Medical Device Co., Ltd.anji Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Anqing Kangmingna Packaging Co.,ltdAnqing Anhui, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
ASP Global, LLCAustell, GA, United StatesSpecification developer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Arion Holding B.V.Heerlen Limburg, NetherlandsManufacturer0000api.fda.gov
Beijing Jinwei Kangda Medical Instrument Ltd.Langfang City Hebei, ChinaManufacturer0000api.fda.gov
Bionest Protez Ortez Rehabilitasyon Malzemeleri Sanayi Ticaret Anonim SirketiYUNUSEMRE Manisa, TurkeyManufacturer0000api.fda.gov
BiosealPlacentia, CA, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Blatchford Products LimitedBASINGSTOKE Hampshire, United KingdomManufacturer0000api.fda.gov
Boen Healthcare Co., Ltd.Suzhou Jiangsu, ChinaExporter to the US, Specification developer0000api.fda.gov
Border Opportunity Saver Systems, Inc.Del Rio, TX, United StatesContract manufacturer0000api.fda.gov
Brace AlignSoddy Daisy, TN, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Breg Mexico, S. De R.L. De C.V. (3)Mexicali Baja California, MexicoManufacturer0000api.fda.gov
Breg Mexico, S. De R.L. De C.V. (4)Mexicali Baja California, MexicoManufacturer, Repackager or relabeler0000api.fda.gov
Breg, Inc.Carlsbad, CA, United StatesSpecification developer0000api.fda.gov
Blatchford, Inc.Miamisburg, OH, United StatesManufacturer0000api.fda.gov
BrainPortfolio Inc.Austin, TX, United StatesSpecification developer0000api.fda.gov
BrownmedSpirit Lake, IA, United StatesManufacturer0000api.fda.gov
Cansin Saglik Gerecleri Sanayi Ve Ticaret A.S.Gebze Kocaeli, TurkeyExporter to the US, Manufacturer0000api.fda.gov
College Park IndustriesWarren, MI, United StatesManufacturer0000api.fda.gov
Deroyal Industries, Inc.Powell, TN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Deroyal Industries, Inc.New Tazewell, TN, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
Deroyal Intercontinental, S.R.L.Santiago, Dominican RepublicContract manufacturer0000api.fda.gov
DJ Orthopedics De Mexico, S.A. De C.V.TIJUANA Baja California, MexicoManufacturer, Repackager or relabeler0000api.fda.gov
DJO TunisiaSfax, TunisiaManufacturer, Repackager or relabeler0000api.fda.gov
DJO TunisieSfax, TunisiaManufacturer0000api.fda.gov
Djo, LLCCarlsbad, CA, United StatesSpecification developer0000api.fda.gov
Dongguan Nan You Sporting Goods Enterprise LtdDongguan Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Dynamic Techno Medicals Private LimitedCoimbatore Tamil Nadu, IndiaContract manufacturer, Manufacturer0000api.fda.gov
Dongguan Park Sport Products Co., Ltd.Dongguan Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Dongguan SAVA Sporting Products Co.,LtdDongguan City Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Edser Insoles S.L.ESPLUGUES DE LLOBREGAT Barcelona, SpainManufacturer0000api.fda.gov
Ethnocare Inc.Montreal Quebec, CanadaManufacturer0000api.fda.gov
Farabloc Development CorporationChilliwack British Columbia, CanadaManufacturer0000api.fda.gov
Fillauer EuropeJARFALLA Stockholm, SwedenManufacturer0000api.fda.gov
Fillauer, LLCChattanooga, TN, United StatesManufacturer0000api.fda.gov
Foam Engineers LtdHigh Wycombe Buckinghamshire, United KingdomManufacturer0000api.fda.gov
Foot Levelers, Inc.Roanoke, VA, United StatesManufacturer0000api.fda.gov
Fillauer CompositesSalt Lake City, UT, United StatesManufacturer0000api.fda.gov
Footmaxx of VirginiaRoanoke, VA, United StatesManufacturer0000api.fda.gov
Foundation Wellness International Co., LTD (FWIL)Binh Duong, VietnamManufacturer0000api.fda.gov
Guangzhou Tian Hong Medical Technology Co., Ltd.Guangzhou Guangdong, ChinaManufacturer0000api.fda.gov
Guatemala Medical ManufacturingVilla Canales Guatemala, GuatemalaContract manufacturer0000api.fda.gov
Hangzhou Alline Plastic Co., Ltd.HANGZHOU Zhejiang, ChinaContract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Hipsaver Inc.Canton, MA, United StatesManufacturer0000api.fda.gov
Hubei Qianjiang Kingphar Medical Material Co., LtdQianjiang, Hubei, ChinaManufacturer0000api.fda.gov
Hugh Steeper LtdLeeds, England, United KingdomComplaint file establishment, Manufacturer0000api.fda.gov
Hengshui Jingkang Medical Device Co.,Ltd.Hengshui City Hebei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Honduras Kitting, S.A.Villanueva Cortes, HondurasContract manufacturer0000api.fda.gov
Industrias Apson S.A de C.VAGUA PRIETA Sonora, MexicoContract manufacturer0000api.fda.gov
Invisible Hand Enterprises, LLCWestminster, CO, United StatesManufacturer0000api.fda.gov
Jandty Health Inc.Taichung, TaiwanRepackager or relabeler, Specification developer0000api.fda.gov
Julius Zorn GMBHAICHACH Bavaria, GermanyManufacturer0000api.fda.gov
Julius Zorn, Inc.Cuyahoga Falls, OH, United StatesManufacturer0000api.fda.gov
Kenad SG Medical, Inc.Bartlett, TN, United StatesContract manufacturer0000api.fda.gov
Liang Cheng Sporting Goods Company LimitedBen Cat Ward Ho Chi Minh, VietnamContract manufacturer, Manufacturer0000api.fda.gov
Maquiladora De Coahuila S De RL De CVCUIDAD ACUNA Coahuila, MexicoContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Medi MFG., Inc.Whitsett, NC, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
Medi Se And Co. KGBAYREUTH Bavaria, GermanySpecification developer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Medstar Healthcare Co.,limitedHuzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Miracle Medical IndustriesEl Obour City Al Qahirah, EgyptContract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Medline Industries, LP - Mexicali (MXC)Mexicali Baja California, MexicoManufacturer, Repackager or relabeler0000api.fda.gov
Medline Soluciones MedicasNuevo Laredo Tamaulipas, MexicoManufacturer0000api.fda.gov
Narang Medical, Ltd.New Delhi, IndiaManufacturer0000api.fda.gov
Narcissus RisingFerndown Dorset, United KingdomManufacturer0000api.fda.gov
Ningbo Ningyuan Import & Export Co., Ltd.Ningbo, Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Northwell HealthManhasset, NY, United StatesManufacturer, Specification developer0000api.fda.gov
O&M Halyard, Inc.Alpharetta, GA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Orliman SluLa Pobla de Vallbona Valencia(Province), SpainManufacturer0000api.fda.gov
Orthomerica Products, Inc.Orlando, FL, United StatesManufacturer0000api.fda.gov
Osborn Medical CorporationCentennial, CO, United StatesManufacturer0000api.fda.gov
OssurNewburgh, NY, United StatesManufacturer0000api.fda.gov
Otto Bock Healthcare CanadaBURLINGTON Ontario, CanadaManufacturer0000api.fda.gov
Otto Bock Healthcare LPSalt Lake City, UT, United StatesManufacturer0000api.fda.gov
Overland Int'l CorporationNew Taipei City, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Ortho Pauher Ind. Com. E Dist. LtdaRecife Pernambuco, BrazilExporter to the US, Foreign private label distributor, Manufacturer0000api.fda.gov
Ortho and Surgical Products Enterprises S.A.Villa Canales Guatemala, GuatemalaContract manufacturer0000api.fda.gov
Ossur Iceland ehf.Reykjavik, IcelandSpecification developer0000api.fda.gov
Otto Bock Healthcare Products GmbHVienna Wien, AustriaManufacturer0000api.fda.gov
Ottobock Manufacturing Bulgaria EOODBlagoevgrad, BulgariaContract manufacturer0000api.fda.gov
Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcare GmbHDUDERSTADT Lower Saxony, GermanyExporter to the US, Manufacturer, Specification developer0000api.fda.gov
Paceline, Inc.Matthews, NC, United StatesManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Productos Medline S.A. De C.V.NUEVO LAREDO Tamaulipas, MexicoManufacturer0000api.fda.gov
Praegear Viet Nam Co., Ltd.Duc Hoa District Long An, VietnamContract manufacturer0000api.fda.gov
Royal Knit Inc.Lees Summit, MO, United StatesManufacturer0000api.fda.gov
Reflex GroupOceanside, CA, United StatesSpecification developer0000api.fda.gov
Secured Ortho Manufacturing Of America, LLCDeer Park, NY, United StatesManufacturer, Specification developer0000api.fda.gov
Shaoxing Annor Textile Company LimitedSHAOXING CITY Zhejiang, ChinaContract manufacturer0000api.fda.gov
Shijiazhuang Aosuo International Trade Co. LtdShijiazhuang Hebei, ChinaComplaint file establishment, Manufacturer0000api.fda.gov
SILIPOS Holding LLCNiagara Falls, NY, United StatesManufacturer0000api.fda.gov
Synthes GMBHZuchwil Solothurn, SwitzerlandSpecification developer0000api.fda.gov
Shijiazhuang Aofeite Medical Device Co.,LtdShijiazhuang Hebei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shock Doctor, Inc.Costa Mesa, CA, United StatesSpecification developer0000api.fda.gov
Skylla SARLAissa Tunis, TunisiaContract manufacturer0000api.fda.gov
Synthes (USA) Products LLCWest Chester, PA, United StatesSpecification developer0000api.fda.gov
Tamarack Habilitation Technologies, Inc.Blaine, MN, United StatesManufacturer0000api.fda.gov
Tex-Care MedicalBurlington, NC, United StatesManufacturer0000api.fda.gov
Tiburon Medical EnterprisesSan Jacinto, CA, United StatesManufacturer0000api.fda.gov
Tien Jiang Enterprise Co., Ltd.Tainan City, TaiwanContract manufacturer, Manufacturer0000api.fda.gov
Tiger Medical GroupShanghai, ChinaExporter to the US, Specification developer0000api.fda.gov
Top Shelf Manufacturing, LLCTracy, CA, United StatesManufacturer0000api.fda.gov
Topwell Group Unit Co., Ltd.Dongguan City Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Tynor Orthotics (P) Ltd.Mohali Punjab, IndiaManufacturer0000api.fda.gov
Thuasne, LLCKansas City, KS, United StatesContract manufacturer, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Touch Bionics LtdLivingston West Lothian, United KingdomSpecification developer0000api.fda.gov
Uniprox GMBH & Co. KGZeulenroda-Triebes Thuringia, GermanyManufacturer0000api.fda.gov
Valentine Intl. Ltd.Hsichih City, Taipei Hsien, TaiwanExporter to the US, Manufacturer0000api.fda.gov
VQ OrthocareVista, CA, United StatesManufacturer0000api.fda.gov
WillowWood Global LLCMt Sterling, OH, United StatesManufacturer0010api.fda.gov
Xiamen Ortocare Sports Health Co.,ltd.Xiamen Free Trade Zone Fujian, ChinaManufacturer0000api.fda.gov
Zhejiang Anji Huabu Industrial Co., Ltd.HUZHOU Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Zhejiang Qiangnao Technology Co.,ltdhangzhou Zhejiang, ChinaContract manufacturer0000api.fda.gov
Zeffer Research & Assoc. S. A. de C. V.Ensenada Baja California, MexicoContract manufacturer, Manufacturer0000api.fda.gov

Updated September 21, 1987. 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.