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FDA 510(k) Clearance Verification

Device Name: SELF-FITTING AIR-CONDUCTION HEARING AID, OVER THE COUNTER

K Number: K221052Sponsor: Huizhou Jinghao Medical Technology Co., Ltd

Last Updated: 04/14/2025

Document Purpose: This file contains official FDA database screenshots verifying 510(k) clearance status for K221052.


1. Official FDA 510(k) Record

1.1 FDA Database Screenshot

1.2 Summary of Clearance Details #

FieldContent
K NumberK221052
Classification NameSELF-FITTING AIR-CONDUCTION HEARING AID, OVER THE COUNTER
Proprietary NameJH-D58,JH-D59FT,JH-DW3F,JH-DW5A,JH-A61HT,JH-A40C,JH-A32E
Product CodeQUH
Device Class2
Medical SpecialtyEar Nose & Throat
Registered Establishment Numbe301158657
Owner/OperatorHuizhou Jinghao Medical Technology Co., Ltd
Owner/Operator Number10048535
Establishment OperationsManufacturer

2. Verification Instructions #

⚠️ This document contains screenshots from the FDA database and is not an official certificate.

1.Visit: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/TextSearch.cfm

2.Search for “K221052

3.Compare: Decision Date,Sponsor Name,Product Code etc..


Disclaimer #

Screenshots were captured on 04/14/2025. For legal purposes, always refer to the current FDA database record. This document does not constitute regulatory advice.

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