Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3032954841

FEI Number

3032954841

Entity Name

WEHEAR INNOVATIONS PRIVATE LIMITED'

City/State/Country

Ahmedabad Gujarat, IN

Establishment Address

805, SUPATH APARTMENT, VIJAY CHAR RASTA, NAVRANGPURA, Ahmedabad Gujarat 380009, IN

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

WEHEAR INNOVATIONS PRIVATE LIMITED' (Owner Number: 10092709)

Owner / Operator Contact Address

805, SUPATH APARTMENT, VIJAY CHAR RASTA, NAVRANGPURA, Ahmedabad, IN-GJ 380009, IN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

RIC OPTIMA 16 RIC OPTIMA 32 BTE OPTIMA PLUS BTE OPTIMA NECKBAND CIC OPTIMA BTE PRIME 32 BTE POWER PLUS RIC OPTIMA 8 CIC PRIME ITE ADVANCE BTE PRIME RIC PRIME 32 ITE PRIME ITE OPTIMA RIC PRIME 16

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ESD	Hearing Aid, Air-Conduction, Prescription	Ear, Nose, Throat	Class 1	874.3300	2025-02-08
OSM	Hearing Aid, Air-Conduction With Wireless Technology, Prescription	Ear, Nose, Throat	Class 2	874.3305	2025-02-18

Official Correspondent

REEPEN SHAH

US Agent Details

JAY LUCAS Business: Wehear USA Email: Jay.Lucas@wehearusa.com Phone: (501) 9515601

Related Public Records

Same Entity

WEHEAR INNOVATIONS PRIVATE LIMITED'

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K892457	Telstar Electronics, Inc.	TELSTAR MODEL 1/3 ITE HEARING AID	1989-06-06
K760996	Unitron Industries, Inc.	HEARING AID (MODEL 695D, 905 & 960P)	1976-11-16
K840825	Maico Hearing Instruments, Inc.	SERIES MR IN-THE-EAR CUSTOM HEARING AID	1984-03-30
K946253	Maico Hearing Instruments, Inc.	MAICO IN-THE-EAR MODEL RD 201	1995-01-30
K863975	Gn Danavox, Inc.	CUSTOM IN-THE-EAR	1986-11-07

Similar Registrations

Registration Number	Establishment Name	Location
3008713760	KENYON AUDIOLOGY	Bend, OR, US
3022507139	Zhongrui HearJoy Medical Equipment co., Ltd.	Shenzhen Guangdong, CN
3005785669	ALPS INTERNATIONAL	NEW DELHI, IN
2523819	MICROSONIC, INC.	AMBRIDGE, PA, US
3017618900	HUIZHOU GOLD ROSE TECHNOLOGY CO.,LTD	huizhou Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3032954841. Last updated year: 2026. Please use registration number 3032954841 when referencing this establishment in official correspondence.