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
| Country | Makers |
|---|---|
| United States | 45 |
| China | 22 |
| Mexico | 9 |
| United Kingdom | 5 |
| Vietnam | 4 |
| Taiwan | 4 |
| Germany | 4 |
| Tunisia | 3 |
| India | 3 |
| Canada | 3 |
| Turkey | 2 |
| Spain | 2 |
| Guatemala | 2 |
| Lithuania | 1 |
| Netherlands | 1 |
| Dominican Republic | 1 |
| Sweden | 1 |
| Honduras | 1 |
| Egypt | 1 |
| Brazil | 1 |
| Iceland | 1 |
| Austria | 1 |
| Bulgaria | 1 |
| Switzerland | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| AB Ortopedijos Technika | Kaunas Kauno Apskritis, Lithuania | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Acode Sporting Goods Company Limited | Ho Chi Minh, Vietnam | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Advance Medical Designs, Inc. | Marietta, GA, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alps South LLC | Saint Petersburg, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anji Hongde Medical Products Co., Ltd. | HUZHOU Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anji Sanfang Medical Device Co., Ltd. | anji Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anqing Kangmingna Packaging Co.,ltd | Anqing Anhui, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ASP Global, LLC | Austell, GA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aspen Surgical Products, Inc. | Caledonia, MI, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arion Holding B.V. | Heerlen Limburg, Netherlands | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beijing Jinwei Kangda Medical Instrument Ltd. | Langfang City Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bionest Protez Ortez Rehabilitasyon Malzemeleri Sanayi Ticaret Anonim Sirketi | YUNUSEMRE Manisa, Turkey | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bioseal | Placentia, CA, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Blatchford Products Limited | BASINGSTOKE Hampshire, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boen Healthcare Co., Ltd. | Suzhou Jiangsu, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Border Opportunity Saver Systems, Inc. | Del Rio, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Brace Align | Soddy Daisy, TN, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Breg Mexico, S. De R.L. De C.V. (3) | Mexicali Baja California, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Breg Mexico, S. De R.L. De C.V. (4) | Mexicali Baja California, Mexico | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Breg, Inc. | Carlsbad, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Blatchford, Inc. | Miamisburg, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BrainPortfolio Inc. | Austin, TX, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Brownmed | Spirit Lake, IA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cansin Saglik Gerecleri Sanayi Ve Ticaret A.S. | Gebze Kocaeli, Turkey | Exporter to the US, 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 | |
| Deroyal Industries, Inc. | New Tazewell, TN, United States | Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Deroyal Intercontinental, S.R.L. | Santiago, Dominican Republic | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DJ Orthopedics De Mexico, S.A. De C.V. | TIJUANA Baja California, Mexico | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| DJO Tunisia | Sfax, Tunisia | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| DJO Tunisie | Sfax, Tunisia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Djo, LLC | Carlsbad, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Nan You Sporting Goods Enterprise Ltd | Dongguan Guangdong, China | Contract manufacturer, 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 | |
| Dongguan Park Sport Products Co., Ltd. | Dongguan Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan SAVA Sporting Products Co.,Ltd | Dongguan City Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Edser Insoles S.L. | ESPLUGUES DE LLOBREGAT Barcelona, Spain | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ethnocare Inc. | Montreal Quebec, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Farabloc Development Corporation | Chilliwack British Columbia, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fillauer Europe | JARFALLA Stockholm, Sweden | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fillauer, LLC | Chattanooga, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Foam Engineers Ltd | High Wycombe Buckinghamshire, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Foot Levelers, Inc. | Roanoke, VA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fillauer Composites | Salt Lake City, UT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Footmaxx of Virginia | Roanoke, VA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Foundation Wellness International Co., LTD (FWIL) | Binh Duong, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Tian Hong Medical Technology Co., Ltd. | Guangzhou Guangdong, China | 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 Alline Plastic Co., Ltd. | HANGZHOU Zhejiang, China | Contract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hipsaver Inc. | Canton, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hubei Qianjiang Kingphar Medical Material Co., Ltd | Qianjiang, Hubei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hugh Steeper Ltd | Leeds, England, United Kingdom | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hengshui Jingkang Medical Device Co.,Ltd. | Hengshui City Hebei, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Honduras Kitting, S.A. | Villanueva Cortes, Honduras | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Industrias Apson S.A de C.V | AGUA PRIETA Sonora, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Invisible Hand Enterprises, LLC | Westminster, CO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jandty Health Inc. | Taichung, Taiwan | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Julius Zorn GMBH | AICHACH Bavaria, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Julius Zorn, Inc. | Cuyahoga Falls, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kenad SG Medical, Inc. | Bartlett, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Liang Cheng Sporting Goods Company Limited | Ben Cat Ward Ho Chi Minh, Vietnam | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Maquiladora De Coahuila S De RL De CV | CUIDAD ACUNA Coahuila, Mexico | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medi MFG., Inc. | Whitsett, NC, United States | Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medi Se And Co. KG | BAYREUTH Bavaria, Germany | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medstar Healthcare Co.,limited | Huzhou Zhejiang, China | Exporter to the US, 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 | |
| Medline Industries, LP - Mexicali (MXC) | Mexicali Baja California, Mexico | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medline Soluciones Medicas | Nuevo Laredo Tamaulipas, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Narang Medical, Ltd. | New Delhi, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Narcissus Rising | Ferndown Dorset, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Ningyuan Import & Export Co., Ltd. | Ningbo, Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Northwell Health | Manhasset, NY, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| O&M Halyard, Inc. | Alpharetta, GA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orliman Slu | La Pobla de Vallbona Valencia(Province), Spain | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orthomerica Products, Inc. | Orlando, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Osborn Medical Corporation | Centennial, CO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ossur | Newburgh, NY, 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 | |
| Otto Bock Healthcare LP | Salt Lake City, UT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Overland Int'l Corporation | New Taipei City, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ortho Pauher Ind. Com. E Dist. Ltda | Recife Pernambuco, Brazil | Exporter to the US, Foreign private label distributor, 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 | |
| Ossur Iceland ehf. | Reykjavik, Iceland | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Otto Bock Healthcare Products GmbH | Vienna Wien, Austria | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ottobock Manufacturing Bulgaria EOOD | Blagoevgrad, Bulgaria | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcare GmbH | DUDERSTADT Lower Saxony, Germany | Exporter to the US, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paceline, Inc. | Matthews, NC, United States | Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Productos Medline S.A. De C.V. | NUEVO LAREDO Tamaulipas, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Praegear Viet Nam Co., Ltd. | Duc Hoa District Long An, Vietnam | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Royal Knit Inc. | Lees Summit, MO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Reflex Group | Oceanside, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Secured Ortho Manufacturing Of America, LLC | Deer Park, NY, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shaoxing Annor Textile Company Limited | SHAOXING CITY Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shijiazhuang Aosuo International Trade Co. Ltd | Shijiazhuang Hebei, China | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SILIPOS Holding LLC | Niagara Falls, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Synthes GMBH | Zuchwil Solothurn, Switzerland | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shijiazhuang Aofeite Medical Device Co.,Ltd | Shijiazhuang Hebei, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shock Doctor, Inc. | Costa Mesa, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Skylla SARL | Aissa Tunis, Tunisia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Synthes (USA) Products LLC | West Chester, PA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tamarack Habilitation Technologies, Inc. | Blaine, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tex-Care Medical | Burlington, NC, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tiburon Medical Enterprises | San Jacinto, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tien Jiang Enterprise Co., Ltd. | Tainan City, Taiwan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tiger Medical Group | Shanghai, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Top Shelf Manufacturing, LLC | Tracy, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Topwell Group Unit Co., Ltd. | Dongguan City Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tynor Orthotics (P) Ltd. | Mohali Punjab, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Thuasne, LLC | Kansas City, KS, United States | Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Touch Bionics Ltd | Livingston West Lothian, United Kingdom | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Uniprox GMBH & Co. KG | Zeulenroda-Triebes Thuringia, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Valentine Intl. Ltd. | Hsichih City, Taipei Hsien, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| VQ Orthocare | Vista, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| WillowWood Global LLC | Mt Sterling, OH, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Xiamen Ortocare Sports Health Co.,ltd. | Xiamen Free Trade Zone Fujian, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Anji Huabu Industrial Co., Ltd. | HUZHOU Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Qiangnao Technology Co.,ltd | hangzhou Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zeffer Research & Assoc. S. A. de C. V. | Ensenada Baja California, Mexico | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.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.