Orest Inc

FDA Filings

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

FDA Registration(s)

• Registration Number: 3015396652
• FEI Number: 3015396652
• Name: OREST, INC.
• Owner & Operator: Orest, Inc.
• Contact Address: 125, Segyosandan-Ro 22 Beon-gil ; Pyeongtaek-si KR-41 Gyeonggido 17843 KR
• Official Correspondent:
  • Ki Duck You
  • 82-31-6108477-x
• US Agent:
  • Priscilla Chung
  • LK Consulting Group USA, Inc.
  • 714 2025789
  • juhee.c@lkconsultinggroup.com
• Importing Logistics Registration:
  • Importer: SAMICK MUSIC CORP. DBA HEALTH MATE
  • Address: 6655 Knott Avenue ; Buena Park, CA 90620 UNITED STATES
  • Phone: 1 714 7396651
  • Importer Type: Agent
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 125, Segyosandan-Ro 22 Beon-gil ; Pyeongtaek-si Gyeonggido, 17843 KR
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
ISA OREST, INC.	ORF-300	2019-04-16
ISA OREST, INC.	OR-8000	2019-04-16
ISA OREST, INC.	OR-7500	2019-04-16
ISA OREST, INC.	OR-7000	2019-04-16
ISA OREST, INC.	OR-6500	2019-04-16
ISA OREST, INC.	OR-6000	2019-04-16
ISA OREST, INC.	OR-5500	2019-04-16
ISA OREST, INC.	OR-5000	2019-04-16
ISA OREST, INC.	OR-4500	2019-04-16
ISA OREST, INC.	OR-4000	2019-04-16
ISA OREST, INC.	OR-3500	2019-04-16
ISA OREST, INC.	OR-3000	2019-04-16
ISA OREST, INC.	OR-1300	2019-04-16
ISA OREST, INC.	HM-8200	2019-04-16
ISA OREST, INC.	HM-7700	2019-04-16
ISA OREST, INC.	HM-6700	2019-04-16
ISA OREST, INC.	HM-6200	2019-04-16
ISA OREST, INC.	HM-5700	2019-04-16
ISA OREST, INC.	HM-5200	2019-04-16
ISA OREST, INC.	HM-4700	2019-04-16
ISA OREST, INC.	HM-4200	2019-04-16
ISA OREST, INC.	HM-3700	2019-04-16
ISA OREST, INC.	HM-3200	2019-04-16

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2019110659063	Pusan,South Korea -> Los Angeles, California	4D MASSAGE CHAIR FOOT PAD MASSAGE CHAIR SPARE PARTS	91 CTN
2019082255372	Pusan,South Korea -> Los Angeles, California	MASSAGE CHAIR	92 CTN
2019040856183	Pusan,South Korea -> Los Angeles, California	4D MASSAGE CHIAR	7 CTN
2019040244307	Pusan,South Korea -> Los Angeles, California	4D MASSAGE CHAIR MASSAGE CHAIR FOOT PAD MASSA GE CHAIR SPARE PARTS	44 PKG
2019011618901	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	MASSAGE CHAIR	70 CTN
2019011431210	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	MASSAGE CHAIR	70 CTN
2018122850975	Pusan,South Korea -> Los Angeles, California	3D MASSAGE CHAIR MASSAGE CHAIR CARPET	68 PKG
2018092065085	Pusan,South Korea -> Los Angeles, California	MASSAGE CHAIR	6 PKG