Data / Medical devices / Support, Hernia
Support, Hernia (EXN): 62 FDA-registered makers in 22 countries
62 establishments in 22 countries are registered with the FDA to make Support, Hernia (product code EXN, Class 1, 21 CFR 876.5970). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on October 26, 1990, and lists 0 recall events (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
- EXN
- Device class
- 1
- Regulation
- 876.5970
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| China | 14 |
| United States | 9 |
| Taiwan | 7 |
| India | 6 |
| United Kingdom | 3 |
| Turkey | 3 |
| Germany | 2 |
| Vietnam | 2 |
| Italy | 2 |
| Latvia | 2 |
| Canada | 1 |
| Netherlands | 1 |
| Chile | 1 |
| Mexico | 1 |
| Cambodia | 1 |
| Colombia | 1 |
| Pakistan | 1 |
| Egypt | 1 |
| Spain | 1 |
| Denmark | 1 |
| Slovakia | 1 |
| Japan | 1 |
Makers of Support, Hernia
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 |
|---|---|---|---|---|---|---|---|---|
| Airway Surgical Appliances Ltd. | NEPEAN Ontario, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alex Orthopedic, Inc. | Grand Prairie, TX, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Basko Healthcare B.V. | ZAANDAM Noord-Holland, Netherlands | Complaint file establishment, Exporter to the US, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Blunding S.A. | MACUL SANTIAGO Region Metropolitana, Chile | 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 | |
| BSN Medical S.A. de C.V. | Reynosa Tamaulipas, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BSN medical Inc. | Charlotte, NC, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bort GmbH | WEINSTADT-BENZACH Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CUI International Limited | Burbage Hinckley Leicestershire, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Core Products International Inc | Chetek, WI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Docbrace (cambodia) Co., Ltd | Phnom Penh Capital, Cambodia | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Redthera Technology Co., Ltd. | Dongguan Guangdong, China | Exporter to the US, Manufacturer | 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 | |
| Foundation Wellness International Co., LTD (FWIL) | Binh Duong, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hameco Hy Co., Ltd | Hung Yen Province, Vietnam | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hengshui Gangsheng Medical Instruments Co., Ltd | Hengshui Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huntex Corporation | Taipei, Taiwan | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Heuer International (A division of GST Corporation Limited) | NOIDA Uttar Pradesh, India | Foreign private label distributor, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| I-Ming Sanitary Materials Co., Ltd. | Changhua, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Indaco S.R.L. | Filiano Potenza, Italy | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Xiangyu Fitness Equipment Co., Ltd. | Yangzhong Jiangsu, China | Contract manufacturer, Exporter to the US, 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 | |
| Kamex International S.A.S | Cajica Cundinamarca, Colombia | Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kosemed Ortopedi Sanayi Ve Ticaret Ithalat Ihracat Anonim Sirketi | Salihli Manisa, Turkey | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Le Shin International Co., Ltd. | Kaohsiung,, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lsez Sia Lauma Medical / Lauma Medical Lsez LLC | Liepaja, Latvia | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lords Mark Industries Ltd. | Daman and Diu Dadra and Nagar Haveli, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| M/S. Ascent Meditech Limited | GOREGAON (E) Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mammon International Corp. | Taipei City, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Melpex Beauty Instruments | Sialkot Punjab, Pakistan | 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 | |
| Neo G Limited | Knaresborough North Yorkshire, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orliman Slu | La Pobla de Vallbona Valencia(Province), Spain | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ottobock SE & Co. KGaA formerly known as Otto Bock Healthcare GmbH | DUDERSTADT Lower Saxony, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pavis S.P.A. | Buguggiate Varese, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Power Well Healthcare Technology Co., Ltd. | Changhua County, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Promedics Orthopaedic Ltd | Port Glasgow Scotland, United Kingdom | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Safe N Simple LLC | Clarkston, MI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shijiazhuang Runyi Medical Device Technology Co.,ltd. | Shijiazhuang Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sia Tonus Elast / Tonus Elast LLC. | Grinvalti,Nicas pag Nicas Novads, Latvia | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Special Protectors Co., Ltd. | New Taipei City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SPM Medicare Pvt, Ltd. | NOIDA Uttar Pradesh, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surgical Appliance Industries, Inc. | Cincinnati, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Kangyouwei Medical Technology Co., Ltd. | Suzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Leison Medical & Healthcare Products Co., Ltd | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shijiazhuang Yide Medical Device Manufacturing Co., Ltd. | Shijiazhuang City Hebei, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tuper Medical Co., Ltd. | Dezhou City Shandong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tynor Orthotics (P) Ltd. | Mohali Punjab, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tytex Denmark A/S | IKAST Midtjylland, Denmark | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tytex Slovakia S.R.O. | HUMENNE Presovsky, Slovakia | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| U.S. Orthotics, Inc. | Tampa, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vizor Ortopedi Medikal Urunleri Pazarlama Ithalat Ihracat Sanayi Ve Ticaret Ltd Sti | KUCUKCEKMECE Istanbul, Turkey | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Variteks Ortopedi Sanayi A.S. | Catalca Istanbul, Turkey | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Women's Medical Research Inc. | Toshima-ku Tokyo, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiamen Chengli Medical Equipment Co., Ltd. | Xiamen Fujian, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiamen Huakang Orthopedic Co.,ltd | Xiamen City Fujian, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiamen J-Brace Medical Equipment Co., Ltd. | Xiamen Fujian, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiamen Longstar Medical Equipment Co.,ltd | Xiamen Fujian, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Rehan Medical Manufacturing Co., Ltd. | Jiaxing City Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 26, 1990. 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.