Kao Chen Enterprise Co L T D

FDA Filings

This page includes the latest FDA filings for Kao Chen Enterprise Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3004129296
• FEI Number: 3004129296
• Name: KAO CHEN ENTERPRISE CO., LTD.
• Owner & Operator: KAO CHEN ENTERPRISE CO., LTD.
• Contact Address: NO. 68, LANE 326, SANGANG RD., LONGJING DISTRICT; TAICHUNG TW-NOTA 434 TW
• Official Correspondent:
  • WANG - Yong-Zong
  • 886-4-26308728-x
• US Agent:
  • John Samorajczyk
  • Samorajczyk Regulatory Consultants, LLC
  • 727 4803810
  • 727 3673212
  • jsamo@prodigy.net
• Importing Logistics Registration:
  • Importer: ADVANCED ORTHOPAEDICS, INC.
  • Address: 326 Main Street ; Harleysville, PA 19438 UNITED STATES
  • Email Address: jlayman31@advanced-orthopaedic
  • Phone: 1 843 6824400
  • FAX: 1 843 6824401
  • Importer Type: Agent
• Importing Logistics Registration:
  • Importer: MACRO INT'L. CO. & MACRO PRODUCTS, INC
  • Address: 78 BUNSEN ; Irvine, CA 92618 UNITED STATES
  • Importer Type: Agent
• Importing Logistics Registration:
  • Importer: MACRO INT'L. CO. & MACRO PRODUCTS, INC.
  • Address: 78 BUNSEN ; Irvine, CA 92618 UNITED STATES
  • Importer Type: Agent
• Importing Logistics Registration:
  • Importer: University Braces
  • Address: 6276 Rivercrest Dr. Suite A riverside, ; Box Springs, CA 92507 UNITED STATES
  • Phone: 1 858 2021522
  • FAX: 1 817 4913774
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: NO. 68, LANE 326, SANGANG RD., ; TAICHUNG Taichung - Municipality, 434 TW
• Establishment Type:
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Manufacture Medical Device

FDA Filings

Device Company	Device	Date
IQK KAO CHEN ENTERPRISE CO., LTD.	Orthosis Cervical	2013-02-03
ITQ KAO CHEN ENTERPRISE CO., LTD.	JOINT, KNEE, EXTERNAL BRACE	2010-02-28
ILE KAO CHEN ENTERPRISE CO., LTD.	Sling, Arm, Overhead Supported	2010-02-28
ITW KAO CHEN ENTERPRISE CO., LTD.	TOWNSEND STABILITY BOOT(TBS)	2006-07-06
ITW KAO CHEN ENTERPRISE CO., LTD.	BOOTIE	2006-07-06
ILH KAO CHEN ENTERPRISE CO., LTD.	AND COMPONENTS PHYSICAL MEDICINE	2004-01-22
IQE KAO CHEN ENTERPRISE CO., LTD.	LUMBAR PHYSICAL MEDICINE	2004-01-16
FQM KAO CHEN ENTERPRISE CO., LTD.	ELASTIC GENERAL HOSPITAL	2004-01-16

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020090911328	Kaohsiung,China (Taiwan) -> New York/Newark Area, Newark, New Jersey	SUPPORTS (LUMBAR SUPPORT) H.S.CODE:9506.91 . . .	15 CTN
2020090447536	Kaohsiung,China (Taiwan) -> Tacoma, Washington	RS LBG GARMENT WITH COLOR EYELETS RS FBG GARMENT EXTENDER LOW BACK GARMENT PACKAGE VELCRO ON OUTSIDE TARIFF FDA DEVICE LISTING	87 CTN
2020090352273	Kaohsiung,China (Taiwan) -> Tacoma, Washington	RS LBG GARMENT WITH COLOR EYELETS RS FBG GARMENT EXTENDER LOW BACK GARMENT PACKAGE VELCRO ON OUTSIDE TARIFF FDA DEVICE LISTING	87 CTN
2020082211327	Kaohsiung,China (Taiwan) -> New York/Newark Area, Newark, New Jersey	SUPPORTS (LUMBAR SUPPORT) H.S.CODE:9506.91 . . .	46 CTN
202008208641	Kaohsiung,China (Taiwan) -> New York/Newark Area, Newark, New Jersey	SUPPORTS (LUMBAR SUPPORT) H.S.CODE:9506.91 . . .	31 CTN
2020073116098	Kaohsiung,China (Taiwan) -> New York/Newark Area, Newark, New Jersey	SUPPORTS (LUMBAR SUPPORT) H.S.CODE:9506.91 . . .	39 CTN
202007044987	Kaohsiung,China (Taiwan) -> New York/Newark Area, Newark, New Jersey	SUPPORTS (LUMBAR SUPPORT) H.S.CODE:9506.91 . . .	46 CTN
202005294922	Kaohsiung,China (Taiwan) -> New York/Newark Area, Newark, New Jersey	SUPPORTS (1.TRANSFORMER-BELT ONLY 2.LUMBAR SUPPORT) H.S.CODE:9506.91 . .	36 CTN