Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3023339161

FEI Number

3023339161

Entity Name

TUNED LTD

City/State/Country

Gan Yoshiya Central, IL

Establishment Address

Harimon, Gan Yoshiya Central 38850, IL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Tuned LTD (Owner Number: 10085651)

Owner / Operator Contact Address

Harimon, Gan Yoshiya, IL-M 38850, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K223848

PMA Number

N/A

All Registered Proprietary Names

Tuned Hearing Mobile App JVC EH-Z2000

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
SCR	Air-Conduction Hearing Aid Software	Ear, Nose, Throat	Class 2	874.3335	2026-03-10
QUH	Self-Fitting Air-Conduction Hearing Aid, Over The Counter	Ear, Nose, Throat	Class 2	874.3325	2023-10-18

Official Correspondent

Omri Gavish

US Agent Details

Shoshana Friedman Business: ProMedoss Email: s.friedman@promedoss.com Phone: (704) 4308695

Related Public Records

Same Entity

Tuned LTD

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3023339161. Last updated year: 2026. Please use registration number 3023339161 when referencing this establishment in official correspondence.