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HEARTWAY MEDICAL PRODUCTS CO., LTD.

Taiwan · Taichung City

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Saudi Arabia, South Korea, Australia — 5 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

pendingnot queried

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

11listed device types

Class I 9Class II 2Class III 0

plus 35 registration records and 23 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class I 2

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

1registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

3active ARTG entries

Class I 3

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States35 registration records, 23 510(k), 0 PMA

Brazil2 confirmed, 0 excluded

Saudi Arabia1 confirmed, 0 excluded

Manufacturer names merged into this page: HEARTWAY MEDICAL PRODUCTS CO., LTD. · Heartway Medical Products Co., Ltd.

FDA 510(k) clearances by year

11997

72007

12008

32009

32010

22014

52015

12022

FDA listed device types

showing 8 of 11

Vehicle, Motorized 3-Wheeled 1Wheelchair, Powered 1Brake, Extension, Wheelchair 1Wheelchair, Mechanical 1Handrim, Wheelchair 1Footrest, Wheelchair 1Device, Anti-Tip, Wheelchair 1Accessories, Wheelchair 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K220227	Auto Folding Scooter, S21F	2022-10-12
US	K151656	HEARTWAY Power Mobility Scooter	2015-11-25
US	K150998	HEARTWAY Power Mobility Scooter	2015-09-29
BR	80791830004	FAMÍLIA CADEIRA DE RODAS MOTORIZADA HEARTWAY	Class I
BR	80791830005	FAMÍLIA SCOOTER MOTORIZADO HEARTWAY	Class I
SA	ME0000014613SFDAA00001	Electrically Powered Wheelchair	—

HEARTWAY MEDICAL PRODUCTS CO., LTD.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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