Heartway Medical Products Co L T D

FDA Filings

This page includes the latest FDA filings for Heartway Medical Products 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: 9616881
• FEI Number: 3002847480
• Name: HEARTWAY MEDICAL PRODUCTS CO., LTD.
• Owner & Operator: HEARTWAY MEDICAL PRODUCTS CO., LTD.
• Contact Address: No.18, Jingke Central 1st Road Nantun Dist.,; Taichung City TW-TXG Taichung - Municipality 40852 TW
• US Agent:
  • SHU-CHEN CHENG
  • ROC CHINESE-EUROPEAN INDUSTRIAL RESEARCH SOCIETY
  • 614 5888168
  • ceirs.jen@msa.hinet.net
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: No.18, Jingke Central 1st Road Nantun Dist.,; TAICHUNG CITY Taichung - District, 40852 TW
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K220227 Heartway Medical Products Co., Ltd.	Auto Folding Scooter, S21F	2022-10-12
GUDID 04719871230497 HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway Medical Products Co., Ltd	2018-07-06
GUDID 04719871230466 HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway Medical Products Co., Ltd	2018-07-06
GUDID 04719871230459 HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway Medical Products Co., Ltd	2018-07-06
GUDID 04719871230442 HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway Medical Products Co., Ltd	2018-07-06
GUDID 04719871230435 HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway Medical Products Co., Ltd	2018-07-06
GUDID 04719871230428 HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway Medical Products Co., Ltd	2018-07-06
GUDID 04719871230411 HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway Medical Products Co., Ltd	2018-07-06
GUDID 04719871230404 HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway Medical Products Co., Ltd	2018-07-06
GUDID 04719871230398 HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway Medical Products Co., Ltd	2018-07-06
GUDID 04719871230381 HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway Medical Products Co., Ltd	2018-07-06
GUDID 04719871230374 HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway Medical Products Co., Ltd	2018-07-06
GUDID 04719871230367 HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway Medical Products Co., Ltd	2018-07-06
GUDID 04719871230350 HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway Medical Products Co., Ltd	2018-07-06
GUDID 04719871230343 HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway Medical Products Co., Ltd	2018-07-06
GUDID 04719871230312 HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway Medical Products Co., Ltd	2018-07-06
GUDID 04719871230305 HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway Medical Products Co., Ltd	2018-07-06
GUDID 04719871230299 HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway Medical Products Co., Ltd	2018-07-06
GUDID 04719871230282 HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway Medical Products Co., Ltd	2018-07-06
GUDID 04719871230251 HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway Medical Products Co., Ltd	2018-07-06
GUDID 04719871230190 HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway Medical Products Co., Ltd	2018-07-06
GUDID 04719871230152 HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway Medical Products Co., Ltd	2018-07-06
GUDID 04719871230145 HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway Medical Products Co., Ltd	2018-07-06
GUDID 04719871230107 HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway Medical Products Co., Ltd	2018-07-06
GUDID 04719871230060 HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway Medical Products Co., Ltd	2018-07-06
GUDID 04719871230015 HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway Medical Products Co., Ltd	2018-07-06
GUDID 04719871230503 HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway Medical Products Co., Ltd	2018-03-29
GUDID 04719871230480 HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway Medical Products Co., Ltd	2018-03-29
GUDID 04719871230473 HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway Medical Products Co., Ltd	2018-03-29
GUDID 04719871230336 HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway Medical Products Co., Ltd	2018-03-29
GUDID 04719871230329 HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway Medical Products Co., Ltd	2018-03-29
GUDID 04719871230275 HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway Medical Products Co., Ltd	2018-03-29
GUDID 04719871230268 HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway Medical Products Co., Ltd	2018-03-29
GUDID 04719871230244 HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway Medical Products Co., Ltd	2018-03-29
GUDID 04719871230237 HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway Medical Products Co., Ltd	2018-03-29
GUDID 04719871230183 HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway Medical Products Co., Ltd	2018-03-29
GUDID 04719871230053 HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway Medical Products Co., Ltd	2018-03-29
GUDID 04719871230039 HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway Medical Products Co., Ltd	2018-03-29
PMN K151656 | INI HEARTWAY MEDICAL PRODUCTS CO., LTD.	HEARTWAY Power Mobility Scooter, Cutie S17	2016-01-29
PMN K151656 HEARTWAY MEDICAL PRODUCTS CO., LTD.	HEARTWAY Power Mobility Scooter	2015-11-25
PMN K150998 | INI HEARTWAY MEDICAL PRODUCTS CO., LTD.	Cute Mini S16 Scooter	2015-10-18
PMN K150987 | INI HEARTWAY MEDICAL PRODUCTS CO., LTD.	BRIO S19 Scooter	2015-10-18
PMN K150998 HEARTWAY Medical Products Co., Ltd.	HEARTWAY Power Mobility Scooter	2015-09-29
PMN K150987 HEARTWAY Medical Products Co., Ltd.	HEARTWAY Power Mobility Scooter, BRIO S19	2015-09-22
PMN K142783 | ITI HEARTWAY MEDICAL PRODUCTS CO., LTD.	HEARTWAY Electrically Powered Wheelchair P27	2015-07-03
PMN K142783 HEARTWAY Medical Products Co., Ltd.	HEARTWAY Electrically Powered Wheelchair P27	2015-06-12
PMN K142731 | ITI HEARTWAY MEDICAL PRODUCTS CO., LTD.	HEARTWAY Electrically Powered Wheelchair, Model P19	2015-03-12
PMN K142731 HEARTWAY Medical Products Co., Ltd.	HEARTWAY Electrically Powered Wheelchairs	2015-02-27
PMN K132856 | ITI HEARTWAY MEDICAL PRODUCTS CO., LTD.	HEARTWAY Power Wheelchair, model P25	2014-11-04
PMN K132855 | INI HEARTWAY MEDICAL PRODUCTS CO., LTD.	HEARTWAY Power Mobility Scooter, model S15	2014-11-04
PMN K132855 HEARTWAY MEDICAL PRODUCTS CO., LTD.	HEARTWAY POWER MOBILITY SCOOTER	2014-08-29
PMN K132856 HEARTWAY MEDICAL PRODUCTS CO., LTD.	HEARTWAY POWER WHEELCHAIR	2014-07-15
PMN K101143 | INI HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway Scooter, S11	2012-11-13
PMN K101142 | INI HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway Scooter, S34	2012-11-13
PMN K100327 | ITI HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway Powered Wheelchair, P23	2012-11-13
PMN K063328 | ITI HEARTWAY MEDICAL PRODUCTS CO., LTD.	HEARTWAY HP6	2011-04-07
PMN K101143 HEARTWAY MEDICAL PRODUCTS CO., LTD.	HEARTWAY POWER MOBILITY SCOOTER, S11	2010-05-26
PMN K101142 HEARTWAY MEDICAL PRODUCTS CO., LTD.	HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S34	2010-05-26
PMN K100327 HEARTWAY MEDICAL PRODUCTS CO., LTD.	HEARTWAY POWER CHAIR, P23	2010-03-22
PMN K080373 | ITI HEARTWAY MEDICAL PRODUCTS CO., LTD.	TACAHE PC1350	2009-12-24
PMN K052534 | ITI HEARTWAY MEDICAL PRODUCTS CO., LTD.	TACAHE	2009-12-24
PMN K092650 | INI HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway S12 Power Mobility Scooter	2009-10-27
PMN K092155 | INI HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway S8 Power Mobility Scooter	2009-10-27
PMN K092154 | INI HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway S9 Power Mobility Scooter	2009-10-27
PMN K092650 HEARTWAY MEDICAL PRODUCTS CO., LTD.	HEARTWAY POWER MOBILITY SCOOTER, S12	2009-10-09
PMN K092155 HEARTWAY MEDICAL PRODUCTS CO., LTD.	HEARTWAY POWER MOBILITY SCOOTER, S8	2009-09-21
PMN K092154 HEARTWAY MEDICAL PRODUCTS CO., LTD.	HEARTWAY POWER MOBILITY SCOOTER, S9	2009-09-21
PMN K020001 | INI HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway	2009-08-10
PMN K063203 | ITI HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway	2008-11-09
PMN K063203 | ITI HEARTWAY MEDICAL PRODUCTS CO., LTD.	HP4	2008-11-09
PMN K031897 | INI HEARTWAY MEDICAL PRODUCTS CO., LTD.	PF2	2008-11-09
PMN K031897 | INI HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway	2008-11-09
PMN K080242 | INI HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway	2008-03-28
PMN K073044 | INI HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway	2008-03-28
PMN K072104 | INI HEARTWAY MEDICAL PRODUCTS CO., LTD.	PF6	2008-03-28
PMN K072104 | INI HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway	2008-03-28
PMN K071007 | INI HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway	2008-03-28
PMN K071006 | ITI HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway	2008-03-28
PMN K071005 | ITI HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway	2008-03-28
PMN K080242 HEARTWAY MEDICAL PRODUCTS CO., LTD.	HEARTWAY POWER MOBILITY SCOOTER, PF7	2008-02-27
PMN K073044 HEARTWAY MEDICAL PRODUCTS CO., LTD.	HEARTWAY POWER MOBILITY SCOOTER, MODEL PT7	2007-12-07
PMN K973491 | IOR HEARTWAY MEDICAL PRODUCTS CO., LTD.	HEARTWAY	2007-11-28
PMN K070493 | INI HEARTWAY MEDICAL PRODUCTS CO., LTD.	HEARTWAY	2007-11-28
PMN K070489 | ITI HEARTWAY MEDICAL PRODUCTS CO., LTD.	HEARTWAY	2007-11-28
PMN K072104 HEARTWAY MEDICAL PRODUCTS CO., LTD.	HEARTWAY POWER MOBILITY SCOOTER, PF6	2007-08-17
PMN K071005 HEARTWAY MEDICAL PRODUCTS CO., LTD.	HEARTWAY LIGHTWEIGHT POWER CHAIR, P15	2007-05-22
PMN K071006 HEARTWAY MEDICAL PRODUCTS CO., LTD.	HEARTWAY ATTENDANT-CONTROLLED POWER CHAIR, TC1	2007-05-21
PMN K071007 HEARTWAY MEDICAL PRODUCTS CO., LTD.	HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S33	2007-04-19
PMN K070493 HEARTWAY MEDICAL PRODUCTS CO., LTD.	HEARTWAY POWER TILT SEATING SYSTEM POWER CHAIR, P17RT	2007-03-23
PMN K070489 HEARTWAY MEDICAL PRODUCTS CO., LTD.	HEARTWAY POWER TILT SEATING SYSTEM POWER CHAIR, MODEL# P16RT	2007-03-14
KNO HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway	1998-01-21
KNN HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway	1998-01-21
IMZ HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway	1998-01-21
IMW HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway	1998-01-21
IMR HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway	1998-01-21
IMO HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway	1998-01-21
IMM HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway	1998-01-21
IML HEARTWAY MEDICAL PRODUCTS CO., LTD.	Heartway	1998-01-21
PMN K973491 HEARTWAY MEDICAL PRODUCTS CO., LTD.	MECHANICAL FOLDING WHEEL CHAIR	1997-12-04

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
202009162266	Pusan,South Korea -> Miami, Florida	POWER SCOOTERS & PARTS HS CODE:8713.90	339 CTN
2020091551861	Taipei,China (Taiwan) -> Los Angeles, California	WHEELCHAIRS AND SPARE PARTS UN NO 3480 IMO CLASS 9 WHEELCHAIRS & SPARE PARTS HS CODE 8713.10,8714.20 FREIGHT COLLECT	66 CTN
202009113133	Pusan,South Korea -> Miami, Florida	POWER SCOOTERS & PARTS HS CODE:8713.90	339 CTN
202009102924	Pusan,South Korea -> Miami, Florida	POWER SCOOTERS & PARTS HS CODE:8713.90	339 CTN
202009093633	Pusan,South Korea -> Miami, Florida	POWER SCOOTERS & PARTS HS CODE:8713.90	339 CTN
202009047565	Kaohsiung,China (Taiwan) -> New York/Newark Area, Newark, New Jersey	POWER DRIVES AND SPARE PARTS	103 CTN
2020082940642	Kaohsiung,China (Taiwan) -> Tacoma, Washington	WHEELCHAIR PARTS HS CODE 871310	80 CTN
202007022674	Pusan,South Korea -> Miami, Florida	POWER SCOOTERS HS CODE:8713.90	250 CTN