Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003778929

FEI Number

3003778929

Entity Name

AMI GLOBAL CO., LTD

City/State/Country

Busan, KR

Establishment Address

22 Beonyoung-ro 104 beon-gil, Jangrim, Saha-gu, Busan 604-845, KR

Establishment Type(s)

Remanufacture Medical Device,Manufacture Medical Device

Owner / Operator

AMI Global Co., Ltd (Owner Number: 9051383)

Owner / Operator Contact Address

22 Beonyoung-ro 104beon-gil, Jangrim, Saha-gu, Busan, KR-26 604-845, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

DR. MED (R) - MULTIPLE ORTHOSIS AND BRACE - DR. MED DR. MED(R) - (MULTIPLE BRANDS) DR. MED(R) - (MULTIPLE BRANDS)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2002-05-27
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2006-06-14
IPX	Orthosis, Rib Fracture, Soft	Physical Medicine	Class 1	890.3490	2006-06-14

Official Correspondent

Sil Keun Yoo

US Agent Details

April Lee Business: Withus Group Inc Email: withus6664@gmail.com Phone: (909) 2749971

Related Public Records

Same Entity

AMI Global Co., Ltd

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-2025	Ossur H F Grjothals 5 Reykjavik Iceland	1	Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101

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2184046	OSBORN MEDICAL CORPORATION	CENTENNIAL, CO, US
3006979871	TRULIFE, LTD.	S. Yorkshire Sheffield, GB
3006137579	ALIGNMED INC.	Irvine, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003778929. Last updated year: 2026. Please use registration number 3003778929 when referencing this establishment in official correspondence.