Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005869201

FEI Number

3005869201

Entity Name

BL Tech Co., Ltd.

City/State/Country

Chuncheon-si Gangwon, KR

Establishment Address

84, Toegyenonggong-ro,, Chuncheon-si Gangwon 24427, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BL TECH CO, LTD. (Owner Number: 9089025)

Owner / Operator Contact Address

84, Toegyenonggong-ro,, Chuncheon-si, KR-42 24427, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

NEAL SPLINT Neal Cutomizing Back Brace Neal Customizing Ankle Brace Neal Customizing Wrist Brace NEAL SKIN PROTECTOR NEAL HYDROGEL PATCH NEAL HYDROGEL SKIN PROTECTOR NEAL HYDROGEL NEAL UNDER PAD

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IQM	Splint, Temporary Training	Physical Medicine	Class 1	890.3025	2006-06-23
IPY	Orthosis, Lumbo-Sacral	Physical Medicine	Class 1	890.3490	2014-11-14
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2014-11-14
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2014-11-14
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2023-01-27
LGF	Component, Cast	Orthopedic	Class 1	888.5940	2007-02-15

Official Correspondent

Jin Woo Bae

US Agent Details

UJU UM Business: Onbix Corp US Email: ONBIXUS@GMAIL.COM Phone: (843) 5828036

Related Public Records

Same Entity

BL TECH 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 3005869201. Last updated year: 2026. Please use registration number 3005869201 when referencing this establishment in official correspondence.