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Data / Medical devices / Orthosis, Truncal, For Dysmenorrhea

Orthosis, Truncal, For Dysmenorrhea (NJB): 10 FDA-registered makers in 5 countries

10 establishments in 5 countries are registered with the FDA to make Orthosis, Truncal, For Dysmenorrhea (product code NJB, 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 1 510(k) clearance under this code, the latest on August 12, 2002, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
NJB
Device class
1
Regulation
890.3490
Medical specialty
Physical Medicine

Makers by country

CountryMakers
China6
Taiwan1
Italy1
Indonesia1
United States1

Makers of Orthosis, Truncal, For Dysmenorrhea

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
Abletech Orthopedics CorporationNew Taipei City Taiwan, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
Aid United International Co., LimitedShanghai, ChinaExporter to the US, Manufacturer0000api.fda.gov
E-Life International Co., LtdYonghe Dist., Taipei, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Indaco S.R.L.Filiano Potenza, ItalyManufacturer0000api.fda.gov
Liven Sports MFG. (xiamen) Co., Ltd.XIAMEN Fujian, ChinaManufacturer0000api.fda.gov
Multi Garmen IndonesiaBOGOR Jawa Barat, IndonesiaContract manufacturer0000api.fda.gov
Orthotech Rehabilitation Co., Ltd.Xiamen Fujian, ChinaExporter to the US, Manufacturer0000api.fda.gov
Robrady Design IncSarasota, FL, United StatesSpecification developer0000api.fda.gov
Zhangpu Ortholife Rehabilitation Co., LtdZhangzhou Fujian, ChinaManufacturer0000api.fda.gov
Zhangzhou Recaring Medical Instrument Co., LtdZhangzhou Fujian, ChinaManufacturer0000api.fda.gov

Updated August 12, 2002. 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.