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Data / Medical devices / Protector, Hearing (Circumaural)

Protector, Hearing (Circumaural) (EWE): 17 FDA-registered makers in 6 countries

17 establishments in 6 countries are registered with the FDA to make Protector, Hearing (Circumaural) (product code EWE, Class U). 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 February 9, 1995, 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.

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Product code
EWE
Device class
U
Medical specialty
Unknown

Makers by country

CountryMakers
China8
United States3
Taiwan2
Canada2
Malaysia1
Mexico1

Makers of Protector, Hearing (Circumaural)

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
Alan Safety CompanyTainan, TaiwanContract manufacturer, Exporter to the US0000api.fda.gov
Ansico (xiamen) Optical Technology Co., Ltd.Xiamen Fujian, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
Canadian Hospital Specialties LtdBurlington Ontario, CanadaSpecification developer0000api.fda.gov
Changzhou Meiguan Care Products Technology Co.,ltd.Changzhou Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
CHS USA IncorporatedPeachtree City, GA, United StatesSpecification developer0000api.fda.gov
Canadian Hospital Specialties Ltd.OAKVILLE Ontario, CanadaManufacturer, Specification developer0000api.fda.gov
F&T Safety Protection Products Co.,ltdNingbo Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Good Horse Toys And Gifts Co.ltdDONGGUAN Guangdong, ChinaContract manufacturer0000api.fda.gov
Guangdong J&y Industrial Co., Ltd.Guangzhou Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Hangzhou Greatstar Industrial Co., LtdHangzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
Hangzhou Greatstar Industrial Co., LtdHangzhou Zhejiang, ChinaExporter to the US, Manufacturer0000api.fda.gov
J&y Safety (M) Sdn. Bhd.SHAH ALAM Selangor, MalaysiaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Jiangyin Sian Plastic Protech Co., Ltd.Jiangyin Jiangsu, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Katecho LLCDes Moines, IA, United StatesContract manufacturer0000api.fda.gov
Neatcap Medical, LLCBethlehem, PA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Sperian Hearing Protection de Mexico S.A. de C.V.Tijuana B.C. Mexico, MexicoSpecification developer0000api.fda.gov
Unique Safety Equipment Co., Ltd.New Taipei City, TaiwanContract manufacturer0000api.fda.gov

Updated February 9, 1995. 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.