Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016096130

FEI Number

3016096130

Entity Name

Soundable Health Korea, Inc. (Subsidiary of Soundable Health, Inc.)

City/State/Country

Seoul, KR

Establishment Address

Suite 324, M+, Magokjungang 8-ro 14, Gangseo-gu, Seoul 07801, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Soundable Health, Inc. (Owner Number: 10061650)

Owner / Operator Contact Address

3003 North 1st Street #221, San Jose, CA 95134, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

proudP

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EXY	Uroflowmeter	Gastroenterology, Urology	Class 2	876.1800	2019-11-07

Official Correspondent

No official correspondent registered.

US Agent Details

Ahnyung Lee Business: SOUNDABLE HEALTH, INC. Email: alee@soundable.health Phone: (858) 2057676

Related Public Records

Same Entity

Soundable Health, Inc.

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 3016096130. Last updated year: 2026. Please use registration number 3016096130 when referencing this establishment in official correspondence.