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Home›USA›Hi-Dow International, Inc.

Hi-Dow International, Inc.

USA · Maryland Heights
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
17listed device types
Class I 7Class II 10Class III 0
plus 24 registration records and 6 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
3 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
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 States24 registration records, 6 510(k), 0 PMA, 7 excluded
Manufacturer names merged into this page: HI-DOW INTERNATIONAL INC. · HI-DOW ELECTRON TECHNOLOGY (HEFEI) INC., LTD · HI-DOW ELECTRON TECHNOLOGY (HEFEI) CO., LTD
Same-named companies — This database also contains companies with near-identical names: HI-DOW ELECTRON TECHNOLOGY (HEFEI) INC., LTD. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Maryland Heights

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

12011 · K102598
12017 · K163393
12019 · K190617
12020 · K202337
12021 · K210383
12024 · K233461

FDA listed device types

showing 8 of 17
Lamp, Infrared, Therapeutic Heating 1Stimulator, Nerve, Transcutaneous, Over-The-Counter 1Stimulator, Muscle, Powered 1Pad, Heating, Powered 1Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature 1Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat 1Electrode, Cutaneous 1Stimulator, Muscle, Powered, For Muscle Conditioning 1

Registration details (sample)

MarketIdentifierNameClass / date
USK233461Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A)2024-01-19
USK210383Wrap Accessory Electrodes2021-11-12
USK202337Pulsed electromagnetic field wrap2020-12-15

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