Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8040255

FEI Number

3010581156

Entity Name

SAEHAN CORPORATION

City/State/Country

Changwon Gyeongnam, KR

Establishment Address

23-29, Bongamgongdan 13-gil, Masanhoewon-Gu (Masan Free Trade Zone), Changwon Gyeongnam 51342, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SAEHAN CORPORATION (Owner Number: 8040255)

Owner / Operator Contact Address

23-29, Bongamgongdan 13-gil, Masanhoewon-Gu (Masan Free Trade Zone), Changwon, KR-48 51342, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SAEHAN Digital Pinch Gauge North Coast Digital Pinch Gauge SAEHAN Digital Hand Dynamometer(DHD-3) SAEHAN Digital Hand Dynamometer(DHD-1) North Coast Digital Hand Dynamometer SAEHAN Digital Hand Dynamometer Multi-Finger Flexion Goniometer(Finger Flexion Gauge) Finger Goniometer SAEHAN X-Ray Goniometer SAEHAN Goniometer SAEHAN Pocket Goniometer SAEHAN Finger Goniometer SAEHAN 6 pcs Goniometer Set 6-Piece Goniometer Set Finger Circumference Gauge Skinfold Caliper SAEHAN Skinfold Caliper Three-Point discriminator SAEHAN Hand Strap for Upper Extremity Exercise(UEE) SAEHAN Upper Extremity Exercise Set SAEHAN Long Front Leg for Upper Extremity Exercise long leg brace kit for deluxe SAEHAN pedal exerciser SAEHAN Extension Arm for Upper Extremity Exercise SAEHAN Parts for Clinical Model Chair Cycle SAEHAN Long Leg Brace Set SAEHAN Bent Leg Brace Set upper extremity exercise kit for deluxe SAEHAN pedal exerciser Iron weights for pulley weight system SAEHAN double handle weight system SAEHAN Cast-Iron Weight Plate SAEHAN Metal Handle(Pair) for Pulley Weights SAEHAN Twin Ball(pair) and Rope for Pulley Weights SAEHAN Guide Rod for Pulley Weights, each SAEHAN Single Column Duplex Pulley Weights SAEHAN Chest Pulley Weights SAEHAN single pulley weight system SAEHAN triple pulley weight system SAEHAN Duplex Pulley Weights SAEHAN Triplex Pulley Weights Back-Leg-Chest Dynamometer SAEHAN Hydraulic Hand Dynamometer Hydraulic Hand Dynamometer Spring Hand Dynamometer North Coast Hydraulic Hand Dynamometer SAEHAN Squeeze Dynamometer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LBB	Dynamometer, Ac-Powered	Orthopedic	Class 2	888.1240	2006-03-20
KQW	Goniometer, Nonpowered	Orthopedic	Class 1	888.1520	1983-01-24
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	1983-01-24
GWI	Discriminator, Two-Point	Neurology	Class 1	882.1200	2018-05-16
IOD	Components, Exercise	Physical Medicine	Class 1	890.5350	1992-05-12
HST	Apparatus, Traction, Non-Powered	Orthopedic	Class 1	888.5850	1993-01-19
HRW	Dynamometer, Nonpowered	Orthopedic	Class 1	888.1250	1983-09-27

Official Correspondent

Sunyoung Park

US Agent Details

Sunyoung Park Email: sypark@szukorea.com Phone: (682) 7729233

Related Public Records

Same Entity

SAEHAN CORPORATION

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 8040255. Last updated year: 2026. Please use registration number 8040255 when referencing this establishment in official correspondence.