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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.

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
KTD
Device class
1
Regulation
890.3490
Medical specialty
Physical Medicine

Makers by country

CountryMakers
China18
United States17
India7
Mexico7
Taiwan6
Vietnam5
Germany4
Canada2
Latvia2
South Korea2
Nicaragua1
Poland1
Chile1
Brazil1
Egypt1
Dominican Republic1
Spain1
Argentina1
Italy1
Turkey1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
A And T Nicaragua, S.A.Masaya, NicaraguaContract manufacturer0000api.fda.gov
Actlife Technology Co., Ltd - Thanh Hoa BranchTrung Chinh Commune Thanh Hoa, VietnamManufacturer0000api.fda.gov
Aid United International Co., LimitedShanghai, ChinaExporter to the US, Manufacturer0000api.fda.gov
Air A Med, LLCFort Myers, FL, United StatesSpecification developer0000api.fda.gov
Airway Surgical Appliances Ltd.NEPEAN Ontario, CanadaManufacturer0000api.fda.gov
Antar SP. J.Warszawa Mazowieckie, PolandManufacturer0000api.fda.gov
Apothecaries Sundries MFG Pvt LtdGURUGRAM Haryana, IndiaManufacturer, Repackager or relabeler0000api.fda.gov
Blunding S.A.MACUL SANTIAGO Region Metropolitana, ChileManufacturer0000api.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
BSN Medical GmbHHamburg, GermanyComplaint file establishment, Specification developer0000api.fda.gov
BSN Medical S.A. de C.V.Reynosa Tamaulipas, MexicoManufacturer0000api.fda.gov
BioSkin LLCAshland, OR, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Bort GmbHWEINSTADT-BENZACH Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Comatrix Technology Vietnam Company LimitedHo Chi Minh City, VietnamContract manufacturer, Manufacturer0000api.fda.gov
Comfort Plus CorporationNew Taipei City, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Core Products Intl., Inc.Osceola, WI, United StatesManufacturer0000api.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 Redthera Technology Co., Ltd.Dongguan Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Dongguan Supercare Medical Products Co., LtdDongguan Guangdong, ChinaExporter to the US, 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
FridaBaby LLCMiami, FL, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Hameco Hy Co., LtdHung Yen Province, VietnamContract manufacturer, Manufacturer0000api.fda.gov
Hebei Youjie Medical Devices Co., LtdShijiazhuang Hebei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Hidrolight Do Brasil SAGAROPABA Santa Catarina, BrazilManufacturer0000api.fda.gov
Hong Ming Enterprise Co., Ltd.Taichung City, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Hengshui Jingkang Medical Device Co.,Ltd.Hengshui City Hebei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Heuer International (A division of GST Corporation Limited)NOIDA Uttar Pradesh, IndiaForeign private label distributor, Manufacturer, Repackager or relabeler0000api.fda.gov
Heye Health Technology Co., Ltd.HuZhou Zhejiang, ChinaManufacturer0000api.fda.gov
Iimed Medical Mexicana S. De R.L. De C.V.Reynosa Tamaulipas, MexicoComplaint file establishment, Contract manufacturer0000api.fda.gov
Jiangsu Reak Healthy Articles Co.,ltdYangzhong City Jiangsu, ChinaManufacturer0000api.fda.gov
Jiangsu Xiangyu Fitness Equipment Co., Ltd.Yangzhong Jiangsu, ChinaManufacturer0000api.fda.gov
Jiundar Industrial Co., Ltd.SHULIN CITY Taipei, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Jiangsu Juneng Sports Goods Technology Co., LtdYangzhou Jiangsu, ChinaManufacturer0000api.fda.gov
L&R Usa Inc.Milwaukee, WI, United StatesSpecification developer0000api.fda.gov
Lsez Sia Lauma Medical / Lauma Medical Lsez LLCLiepaja, LatviaContract manufacturer, Manufacturer0000api.fda.gov
Lords Mark Industries Ltd.Daman and Diu Dadra and Nagar Haveli, IndiaManufacturer0000api.fda.gov
M/S. Ascent Meditech LimitedGOREGAON (E) Maharashtra, IndiaManufacturer0000api.fda.gov
Mammon International Corp.Taipei City, TaiwanExporter to the US, Manufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Medtech Acuna S.A. De C.V.Acuna Coahuila, MexicoContract manufacturer0000api.fda.gov
MGRM Medicare Ltd.Khairatabad, Hyderabad Andhra Pradesh, IndiaManufacturer0000api.fda.gov
Miracle Medical IndustriesEl Obour City Al Qahirah, EgyptContract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler0000api.fda.gov
Motion TherapeuticsFolsom, CA, United StatesManufacturer0000api.fda.gov
Neomed Co., Ltd.Saha-gu Busan, South KoreaManufacturer0000api.fda.gov
Optec Usa, IncSan Pedro De Macoris, Dominican RepublicManufacturer0000api.fda.gov
Optec Usa, Inc.Lawrenceville, GA, United StatesManufacturer0000api.fda.gov
Orliman SluLa Pobla de Vallbona Valencia(Province), SpainManufacturer0000api.fda.gov
P.C.P. ChampionRipley, OH, United StatesManufacturer0000api.fda.gov
Pantymed S.A.BUENOS AIRES Buenos Aires, Ciudad Autonoma de, ArgentinaManufacturer0000api.fda.gov
Portland Garment FactoryPortland, OR, United StatesContract manufacturer0000api.fda.gov
Pro-Tech InternationalRaynham, MA, United StatesManufacturer0000api.fda.gov
Professional Products, Inc.Defuniak Spgs, FL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Picard Healthcare Technology (Dongguan) Co. LtdDongguan Guangdong, ChinaManufacturer0000api.fda.gov
Qualiteam S.R.L.Burolo Piedmont, ItalyManufacturer0000api.fda.gov
Reak Vietnam Company LimitedNhon Trach Commune Dong Nai, VietnamExporter to the US, Manufacturer0000api.fda.gov
Rival Vietnam Co.,ltdHung Yen Province, VietnamContract manufacturer, Manufacturer0000api.fda.gov
Shijiazhuang Runyi Medical Device Technology Co.,ltd.Shijiazhuang Hebei, ChinaManufacturer0000api.fda.gov
Sia Tonus Elast / Tonus Elast LLC.Grinvalti,Nicas pag Nicas Novads, LatviaContract manufacturer, Manufacturer0000api.fda.gov
Spio Inc.Burien, WA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
SPORLASTIC GMBH & Co.KGNURTINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Surgical Appliance Industries, Inc.Cincinnati, OH, United StatesManufacturer0000api.fda.gov
Tecma Operaciones S. De R.L. De C.V.Juarez Chihuahua, MexicoManufacturer0000api.fda.gov
The Marena Group, LLC.Lawrenceville, GA, United StatesManufacturer0000api.fda.gov
Thuasne Deutschland GMBHBurgwedel Lower Saxony, GermanyManufacturer0000api.fda.gov
Trulife LimitedTRENTON Ontario, CanadaManufacturer0000api.fda.gov
Tynor Orthotics (P) Ltd.Mohali Punjab, IndiaManufacturer0000api.fda.gov
Valentine Intl. Ltd.Hsichih City, Taipei Hsien, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Value & Trust Co., Ltd.Daegu, South KoreaManufacturer0000api.fda.gov
Variteks Ortopedi Sanayi A.S.Catalca Istanbul, TurkeyManufacturer0000api.fda.gov
Xiamen Chengli Medical Equipment Co., Ltd.Xiamen Fujian, ChinaManufacturer0000api.fda.gov
Xiamen J-Brace Medical Equipment Co., Ltd.Xiamen Fujian, ChinaManufacturer0000api.fda.gov
Yangzhou Feiyali Sporting Goods Co.ltdYangzhou Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Yangzhou Juli Sports Articles Co.,ltd.YangZhou Jiangsu, ChinaManufacturer0000api.fda.gov
Yasco Enterprise Corp.Chiayi County Chiayi(County), TaiwanExporter to the US, Manufacturer0000api.fda.gov
Zhongshan Chukuang Textile Co., Ltd.Zhongshan City, Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.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.