Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016831175

FEI Number

3016831175

Entity Name

INTOBORN CO., LTD.

City/State/Country

Gimhae-si Gyeongnam, KR

Establishment Address

212, 1st bld, 88, Somang-gil, Juchon-myeon, Gimhae-si Gyeongnam 50969, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

INTOBORN CO., LTD. (Owner Number: 10072063)

Owner / Operator Contact Address

212, 1st bld, 88, Somang-gil, Juchon-myeon, Gimhae-si, KR-48 50963, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ELYSIUM PET-CARON ELYSIUM EYE 900 ELYSIUM ZEUS & HERA ELYSIUM PET-HERA Whata153 ELYSIUM PET-CARON ELYSIUM PET-HERA ELYSIUM ZEUS & HERA ELYSIUM EYE 900 Whata153

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2020-04-26
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2020-04-26

Official Correspondent

No official correspondent registered.

US Agent Details

Krallum Uju Business: Onbix Corp US Email: onbixus@gmail.com Phone: (843) 5828036

Related Public Records

Same Entity

INTOBORN CO., LTD.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K881862	Thermo Body Wrap Systems, Inc.	THERMO-BODY-WRAP SYSTEM	1988-10-13

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3030407739	CL MEDIX INC	Chantilly, VA, US
3009079475	Aerotel Ltd.	Holon Central, IL
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016831175. Last updated year: 2026. Please use registration number 3016831175 when referencing this establishment in official correspondence.