Saehan Corp

FDA Filings

This page includes the latest FDA filings for Saehan Corp. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

Registration Number

8040255

FEI Number

3010581156

Name

SAEHAN CORPORATION

Owner & Operator

SAEHAN CORPORATION

Contact Address

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

Official Correspondent

Priscilla Chung
82-55-2940381-x

US Agent

Priscilla Chung
LK Consulting Group USA, Inc.
714 2025789
juhee.c@lkconsultinggroup.com

Importing Logistics Registration

Importer	Grip Repair, Inc.
Address	1081-B State Route 28, Suite 112 Milford, OH 45150 UNITED STATES
Importer Type	Agent

Importing Logistics Registration

Importer	Power Systems, Inc
Address	5700 Casey Drive Knoxville, TN 37909 UNITED STATES
Importer Type	Agent

Registration Status

Initial Importer

Registration Expiration

2020-04-25

Registration Address

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

Establishment Type

Manufacture Medical Device

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
GWY SAEHAN CORPORATION	Wartenberg Pinwheel	2018-05-16
GWI SAEHAN CORPORATION	Three-Point discriminator	2018-05-16
PMN K052309 \| LBB SAEHAN CORPORATION	SAEHAN Digital Pinch Gauge	2006-03-20
PMN K052309 \| LBB SAEHAN CORPORATION	SAEHAN Digital Hand Dynamometer	2006-03-20
PMN K052309 \| LBB SAEHAN CORPORATION	North Coast Digital Pinch Gauge	2006-03-20
PMN K052309 \| LBB SAEHAN CORPORATION	North Coast Digital Hand Dynamometer	2006-03-20
PMN K052309 SAEHAN CORP.	DIGITAL HAND DYNAMOMETER, MODEL SH5003; DIGITAL PINCH GAUGE, MODEL SH5006	2005-09-27
HST SAEHAN CORPORATION	SAEHAN triple pulley weight system	1993-01-19
HST SAEHAN CORPORATION	SAEHAN single pulley weight system	1993-01-19
HST SAEHAN CORPORATION	SAEHAN double handle weight system	1993-01-19
HST SAEHAN CORPORATION	SAEHAN Twin Ball(pair) and Rope for Pulley Weights	1993-01-19
HST SAEHAN CORPORATION	SAEHAN Triplex Pulley Weights	1993-01-19
HST SAEHAN CORPORATION	SAEHAN Single Column Duplex Pulley Weights	1993-01-19
HST SAEHAN CORPORATION	SAEHAN Metal Handle(Pair) for Pulley Weights	1993-01-19
HST SAEHAN CORPORATION	SAEHAN Guide Rod for Pulley Weights, each	1993-01-19
HST SAEHAN CORPORATION	SAEHAN Duplex Pulley Weights	1993-01-19
HST SAEHAN CORPORATION	SAEHAN Chest Pulley Weights	1993-01-19
HST SAEHAN CORPORATION	SAEHAN Cast-Iron Weight Plate	1993-01-19
HST SAEHAN CORPORATION	Iron weights for pulley weight system	1993-01-19
HTJ SAEHAN CORPORATION	SAEHAN Mechanical Pinch Gauge	1992-09-01
HTJ SAEHAN CORPORATION	SAEHAN Hydraulic Pinch Gauge	1992-09-01
HTJ SAEHAN CORPORATION	North Coast Hydraulic Pinch Gauge	1992-09-01
HTJ SAEHAN CORPORATION	Hydraulic Pinch Gauge	1992-09-01
ION SAEHAN CORPORATION	SAEHAN deluxe chair cycle pedal exerciser	1992-05-12
ION SAEHAN CORPORATION	SAEHAN chair cycle pedal exerciser	1992-05-12
ION SAEHAN CORPORATION	SAEHAN Chair Cycle, Home Model	1992-05-12
ION SAEHAN CORPORATION	SAEHAN Chair Cycle, Clinical Model	1992-05-12
ION SAEHAN CORPORATION	Chair Cycle, Deluxe Home Model	1992-05-12
ION SAEHAN CORPORATION	Chair Cycle, Clinic Model	1992-05-12
IOD SAEHAN CORPORATION	upper extremity exercise kit for deluxe SAEHAN pedal exerciser	1992-05-12
IOD SAEHAN CORPORATION	long leg brace kit for deluxe SAEHAN pedal exerciser	1992-05-12
IOD SAEHAN CORPORATION	SAEHAN Upper Extremity Exercise Set	1992-05-12
IOD SAEHAN CORPORATION	SAEHAN Parts for Clinical Model Chair Cycle	1992-05-12
IOD SAEHAN CORPORATION	SAEHAN Long Leg Brace Set	1992-05-12
IOD SAEHAN CORPORATION	SAEHAN Long Front Leg for Upper Extremity Exercise	1992-05-12
IOD SAEHAN CORPORATION	SAEHAN Hand Strap for Upper Extremity Exercise(UEE)	1992-05-12
IOD SAEHAN CORPORATION	SAEHAN Extension Arm for Upper Extremity Exercise	1992-05-12
IOD SAEHAN CORPORATION	SAEHAN Bent Leg Brace Set	1992-05-12
HRW SAEHAN CORPORATION	SAEHAN Squeeze Dynamometer	1983-09-27
HRW SAEHAN CORPORATION	SAEHAN Hydraulic Hand Dynamometer	1983-09-27
HRW SAEHAN CORPORATION	North Coast Hydraulic Hand Dynamometer	1983-09-27
HRW SAEHAN CORPORATION	Hydraulic Hand Dynamometer	1983-09-27
HRW SAEHAN CORPORATION	Back-Leg-Chest Dynamometer	1983-09-27
KQW SAEHAN CORPORATION	SAEHAN X-Ray Goniometer	1983-01-24
KQW SAEHAN CORPORATION	SAEHAN Pocket Goniometer	1983-01-24
KQW SAEHAN CORPORATION	SAEHAN Goniometer	1983-01-24
KQW SAEHAN CORPORATION	SAEHAN Finger Goniometer	1983-01-24
KQW SAEHAN CORPORATION	SAEHAN 6 pcs Goniometer Set	1983-01-24
KQW SAEHAN CORPORATION	Multi-Finger Flexion Goniometer(Finger Flexion Gauge)	1983-01-24
KQW SAEHAN CORPORATION	Finger Goniometer	1983-01-24
KQW SAEHAN CORPORATION	6-Piece Goniometer Set	1983-01-24
FTY SAEHAN CORPORATION	Skinfold Caliper	1983-01-24
FTY SAEHAN CORPORATION	SAEHAN Skinfold Caliper	1983-01-24
FTY SAEHAN CORPORATION	Finger Circumference Gauge	1983-01-24

Similar & Related FDA Registered Companies

SAEHAN MED CORP

Related Finance Registrations

NCAGE Code	793AF	SAEHAN CORPORATION
CAGE Code	793AF	SAEHAN CORPORATION

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020081729334	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	SAEHAN DOUBLE PULLEY WEIGHT SYSTEM 9506.91	1 PKG
2020053042714	Pusan,South Korea -> Long Beach, California	MECHANO-THERAPY APPLIANCES 9019.10-1000	1 PKG
2020042223882	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	PHYSICAL EXERCISE ARTICLES	2 PKG
202004213837	Hong Kong,Hong Kong -> Miami, Florida	MECHANO-THERAPY APPLIANCES THIS SHIPMENT CONTAINS NO WOOD PACKAGING MATERIALS	1 PKG
2020020852121	Pusan,South Korea -> Los Angeles, California	MECHANO-THERAPY APPLIANCES 9019.10-1000	1 PKG
2020020129629	Pusan,South Korea -> Long Beach, California	HYDRAULIC HAND DYNAMOMETER	2 PKG
2019050320952	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	SAEHAN SINGLE HANDLE WEIGHT SYSTEM 9506.91	1 PKG
2019042369446	Pusan,South Korea -> Long Beach, California	5 PKGS OF . EXACTA HAND EVALUATION KIT,3PCS,HARD CASE HARD HELMET WHITE MEDIUM NORTH COAST HYDRAULIC HAND DYNAMOMETER,HARD CASE NORTH COAST HYDRAULIC PINCH GAUGE,HARD CASE	5 PKG