HomeChinaGymmax Technology Shenzen Co., Ltd.

Gymmax Technology Shenzen Co., Ltd.

China · Shenzhen City
✓ 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
pendingnot queried
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
9listed device types
Class I 0Class II 9Class III 0
plus 16 registration records and 3 510(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
1active device licences
Class II 1
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 States16 registration records, 3 510(k), 0 PMA, 1 excluded
Canada1 confirmed, 0 excluded
Manufacturer names merged into this page: GYMMAX TECHNOLOGY SHENZHEN CO., LTD · GYMMAX TECHNOLOGY SHENZHEN CO., LTD.
Same-named companies — This database also contains companies with near-identical names: Gymmax Technology Shenzhen Co., Ltd.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
China
City
Shenzhen City

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

12020 · K192201
22024 · K240108

FDA listed device types

showing 8 of 9
Lamp, Infrared, Therapeutic Heating 1Stimulator, Nerve, Transcutaneous, Over-The-Counter 1Light Based Over The Counter Wrinkle Reduction 1Electrode, Cutaneous 1Stimulator, Muscle, Powered, For Muscle Conditioning 1Over-The-Counter Powered Light Based Laser For Acne 1Stimulator, Electrical, Transcutaneous, For Arthritis 1Powered Laser Surgical Instrument 1

Registration details (sample)

MarketIdentifierNameClass / date
USK240108Wrap Accessory Electrodes (GMX-ABSBELT01; GMX-ABSBELT02; GMX-WRIST01; GMX-ELBOW01; GMX-LEG01, GMX-ANKLE01, GMX-KNEE01; GMX-FOOT PAD01; GMX-GLOVES01; SHOULDER01; GMX-NCK01)2024-06-10
USK232439Electrical Stimulator System2024-03-21
USK192201Electrical Stimulator System2020-06-12
CA106151ACNE TREATMENT DEVICEClass II

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