# GH INNOTEK CO., LTD.

FEI: 3015972815
Status: Active
Establishment types: Manufacture Medical Device
Owner/operator: GH Innotek Co., Ltd. (#10084379)

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

Mandatory US Agent: J.S. CHEM INTERNATIONAL CO.

## Products

Total registered: 1
Top product codes: ION
Regulation §: 890.5370

Proprietary names: Bigbreathe Double Action IMT/PEP, Bigbreathe S-IMT, Bigbreathe BreST Mask, Bigbreathe IMT, Bigbreathe Double Action V-PEP/IMT, IMT/PEP 100, Bigbreathe Double Action O-PEP/IMT

## Source

- openFDA: https://api.fda.gov/device/registrationlisting.json?search=registration.fei_number:%223015972815%22
- FDA Registration Lookup: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=3015972815