Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011806255

FEI Number

3011806255

Entity Name

MAN & TEL COMPANY LIMITED

City/State/Country

Gumi-Si Gyeongbuk, KR

Establishment Address

258 Saneop-ro, Gumi-Si Gyeongbuk 39232, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MAN & TEL COMPANY LIMITED (Owner Number: 10049655)

Owner / Operator Contact Address

258 Saneop-ro, Gumi-Si, KR-47 39232, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

3DBT-11 (3D Balance Trainer) 3DBT-12 (3D Balance Trainer) ML-10 (Electric Patient Lift) 3DBT-2 (3D Balance Trainer) 3DBT-81 (3D Sliding Vertical Balance Trainer) 3DBT-81-A (Sliding Balance Trainer) 3DBT-61 (Upper Limb Rehabilitation Robot Trainer) 3DBT-33 (Trunk Stability Rehabilitation Robot Trainer) SBT-390 (Vestibular Trainer(Dynamic Posturograpy)) MSVV-100 (Subjective Visual Vertical checker) TBT-100 (Body Balance Trainer) 3DBT-25 (Standing and Balance Trainer) MSBT-10 (Sliding Balance Trainer) 3DBT-26 (Standing and Balance Trainer)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IKK	System, Isokinetic Testing And Evaluation	Physical Medicine	Class 2	890.1925	2015-07-06
FNG	Lift, Patient, Ac-Powered	General Hospital	Class 2	880.5500	2021-06-10
PKS	Exerciser, Non-Measuring For Stroke Rehabilitation	Physical Medicine	Class 1	890.5370	2017-03-07
IRR	Bars, Parallel, Powered	Physical Medicine	Class 1	890.5380	2017-08-24
ISD	Exerciser, Measuring	Physical Medicine	Class 2	890.5360	2016-01-26
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	2017-08-28

Official Correspondent

Suk Kihl

US Agent Details

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

Related Public Records

Same Entity

MAN & TEL COMPANY LIMITED

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
K912769	Century Manufacturing Co.	PATIENT LIFT AND TRANSPORT	1991-10-02

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011806255. Last updated year: 2026. Please use registration number 3011806255 when referencing this establishment in official correspondence.