Data / Medical devices / Protector, Hearing (Insert)
Protector, Hearing (Insert) (EWD): 35 FDA-registered makers in 9 countries
35 establishments in 9 countries are registered with the FDA to make Protector, Hearing (Insert) (product code EWD, 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 14 510(k) clearances under this code, the latest on June 25, 2002, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- EWD
- Device class
- U
- Medical specialty
- Unknown
Makers by country
| Country | Makers |
|---|---|
| China | 13 |
| United States | 11 |
| Taiwan | 3 |
| Malaysia | 2 |
| Hong Kong | 2 |
| Germany | 1 |
| Thailand | 1 |
| India | 1 |
| Mexico | 1 |
Makers of Protector, Hearing (Insert)
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 |
|---|---|---|---|---|---|---|---|---|
| Alan Safety Company | Tainan, Taiwan | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alan Safety Company- Industrial Park Plant | Tainan, Taiwan | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ansico (xiamen) Optical Technology Co., Ltd. | Xiamen Fujian, China | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| Apothecary Products, LLC. | Burnsville, MN, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changzhou Recoo Healthcare Co., Ltd. | Changzhou Jiangsu, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cirrus Healthcare Products LLC | East Dorset, VT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cixi Bohong Bath Appliances Co., Ltd. | Ningbo Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Detax GMBH | ETTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangdong J&y Industrial Co., Ltd. | Guangzhou Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Junyue Foam Earplug Co.,ltd. | GUANGZHOU CITY Guangdong, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hana Microelectronics Public Co.,ltd. | A. Muang Lamphun, Thailand | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Greatstar Industrial Co., Ltd | Hangzhou Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huizhou Gold Rose Technology Co.,ltd | huizhou Guangdong, China | Contract manufacturer, Exporter to the US, Foreign private label distributor, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Insta-Mold Products, Inc. | Oaks, PA, United States | Manufacturer, Reprocessor, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| J&y Safety (M) Sdn. Bhd. | SHAH ALAM Selangor, Malaysia | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Junhe Industry And Trade Co.,ltd | Yangjiang Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangyin Sian Plastic Protech Co., Ltd. | Jiangyin Jiangsu, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| K-One MediTech Sdn. Bhd | Ipoh Perak, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kaizen Dynamic Limited | Hong Kong, Hong Kong | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kobayashi America Manufacturing, LLC | Dalton, GA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mckeon Products, Inc. | Warren, MI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Microsonic, Inc. | Ambridge, PA, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo R&m(rato) International Trading Co., Ltd. | NINBGO Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ozone Audio LLC | Schaumburg, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pro-Optics LLC | Palatine, IL, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Samson Innovation Corp. Ltd. | Kowloon, Hong Kong | Exporter to the US, Foreign private label distributor, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scope Medical Devices Private Limited | Ambala City Haryana, India | Foreign private label distributor, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sperian Hearing Protection de Mexico S.A. de C.V. | Tijuana B.C. Mexico, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Unique Safety Equipment Co., Ltd. | New Taipei City, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Unplugs Hearing Inc | Brooklyn, NY, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| We Are Dreamers LLC | Los Angeles, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Westone Laboratories, Inc. | Colorado Springs, CO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wuhan Jinshengyuan Textile Manufacturing Co Ltd. | Wuhan Hubei, China | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Baron Travel Products Co.,ltd | JINHUA CITY Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Longmed Medical Technology Co., Ltd. | Huzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 25, 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.