Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015972815

FEI Number

3015972815

Entity Name

GH INNOTEK CO., LTD.

City/State/Country

Geumjeong-gu Busan, KR

Establishment Address

2F, Room B2, 68, Busandaehak-ro 50beon-gil, Geumjeong-gu Busan 46285, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

GH Innotek Co., Ltd. (Owner Number: 10084379)

Owner / Operator Contact Address

2F, Room B2, 68, Busandaehak-ro 50beon-gil,, Geumjeong-gu, KR-26 46285, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

IMT/PEP 100 Bigbreathe BreST Mask Bigbreathe IMT Bigbreathe Double Action IMT/PEP Bigbreathe S-IMT Bigbreathe Double Action V-PEP/IMT Bigbreathe Double Action O-PEP/IMT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	2022-02-15

Official Correspondent

No official correspondent registered.

US Agent Details

Grace Kim Business: J.S. CHEM INTERNATIONAL CO. Email: gracejschem@hotmail.com Phone: (310) 5983012

Related Public Records

Same Entity

GH Innotek Co., 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 3015972815. Last updated year: 2026. Please use registration number 3015972815 when referencing this establishment in official correspondence.