Data / Medical devices / Orthosis, Abdominal
Orthosis, Abdominal (KTD): 80 FDA-registered makers in 20 countries
80 establishments in 20 countries are registered with the FDA to make Orthosis, Abdominal (product code KTD, Class 1, 21 CFR 890.3490). 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 December 30, 1982, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KTD
- Device class
- 1
- Regulation
- 890.3490
- Medical specialty
- Physical Medicine
Makers by country
| Country | Makers |
|---|---|
| China | 18 |
| United States | 17 |
| India | 7 |
| Mexico | 7 |
| Taiwan | 6 |
| Vietnam | 5 |
| Germany | 4 |
| Canada | 2 |
| Latvia | 2 |
| South Korea | 2 |
| Nicaragua | 1 |
| Poland | 1 |
| Chile | 1 |
| Brazil | 1 |
| Egypt | 1 |
| Dominican Republic | 1 |
| Spain | 1 |
| Argentina | 1 |
| Italy | 1 |
| Turkey | 1 |
Makers of Orthosis, Abdominal
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 |
|---|---|---|---|---|---|---|---|---|
| A And T Nicaragua, S.A. | Masaya, Nicaragua | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Actlife Technology Co., Ltd - Thanh Hoa Branch | Trung Chinh Commune Thanh Hoa, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aid United International Co., Limited | Shanghai, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Air A Med, LLC | Fort Myers, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Airway Surgical Appliances Ltd. | NEPEAN Ontario, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Antar SP. J. | Warszawa Mazowieckie, Poland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Apothecaries Sundries MFG Pvt Ltd | GURUGRAM Haryana, India | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Blunding S.A. | MACUL SANTIAGO Region Metropolitana, Chile | Manufacturer | 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 | |
| BSN Medical GmbH | Hamburg, Germany | Complaint file establishment, 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 | |
| BioSkin LLC | Ashland, OR, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bort GmbH | WEINSTADT-BENZACH Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Comatrix Technology Vietnam Company Limited | Ho Chi Minh City, Vietnam | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Comfort Plus Corporation | New Taipei City, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Core Products Intl., Inc. | Osceola, WI, United States | 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, LLC | Carlsbad, CA, United States | Specification developer | 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 | |
| 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 | |
| FridaBaby LLC | Miami, FL, United States | Complaint file establishment, Specification developer | 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 | |
| Hebei Youjie Medical Devices Co., Ltd | Shijiazhuang Hebei, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hidrolight Do Brasil SA | GAROPABA Santa Catarina, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hong Ming Enterprise Co., Ltd. | Taichung City, Taiwan | Exporter to the US, 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 | |
| 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 | |
| Heye Health Technology Co., Ltd. | HuZhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Iimed Medical Mexicana S. De R.L. De C.V. | Reynosa Tamaulipas, Mexico | Complaint file establishment, Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Reak Healthy Articles Co.,ltd | Yangzhong City Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Xiangyu Fitness Equipment Co., Ltd. | Yangzhong Jiangsu, China | 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 | |
| Jiangsu Juneng Sports Goods Technology Co., Ltd | Yangzhou Jiangsu, China | 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 | |
| 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 | |
| Medtech Acuna S.A. De C.V. | Acuna Coahuila, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MGRM Medicare Ltd. | Khairatabad, Hyderabad Andhra Pradesh, India | 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 | |
| Motion Therapeutics | Folsom, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Neomed Co., Ltd. | Saha-gu Busan, South Korea | Manufacturer | 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 | |
| Orliman Slu | La Pobla de Vallbona Valencia(Province), Spain | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| P.C.P. Champion | Ripley, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pantymed S.A. | BUENOS AIRES Buenos Aires, Ciudad Autonoma de, Argentina | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Portland Garment Factory | Portland, OR, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pro-Tech International | Raynham, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Professional Products, Inc. | Defuniak Spgs, FL, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Picard Healthcare Technology (Dongguan) Co. Ltd | Dongguan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Qualiteam S.R.L. | Burolo Piedmont, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Reak Vietnam Company Limited | Nhon Trach Commune Dong Nai, Vietnam | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rival Vietnam Co.,ltd | Hung Yen Province, Vietnam | Contract manufacturer, 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 | |
| Spio Inc. | Burien, WA, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SPORLASTIC GMBH & Co.KG | NURTINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surgical Appliance Industries, Inc. | Cincinnati, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tecma Operaciones S. De R.L. De C.V. | Juarez Chihuahua, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| The Marena Group, LLC. | Lawrenceville, GA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Thuasne Deutschland GMBH | Burgwedel Lower Saxony, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Trulife Limited | TRENTON Ontario, Canada | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tynor Orthotics (P) Ltd. | Mohali Punjab, India | 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 | |
| Value & Trust Co., Ltd. | Daegu, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Variteks Ortopedi Sanayi A.S. | Catalca Istanbul, Turkey | 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 J-Brace Medical Equipment Co., Ltd. | Xiamen Fujian, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yangzhou Feiyali Sporting Goods Co.ltd | Yangzhou Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yangzhou Juli Sports Articles Co.,ltd. | YangZhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yasco Enterprise Corp. | Chiayi County Chiayi(County), Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhongshan Chukuang Textile Co., Ltd. | Zhongshan City, Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated December 30, 1982. 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.