ZMI ELECTRONICS LTD.

Address:6F-1, NO. 286-4, SHIN YA RD,KAOHSIUNG,TW

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Electrode, Cutaneous (GXY) (4) Stimulator, Muscle, Powered, For Muscle Conditioning (NGX) (1)

Premarket Exempt

No Yes

Clear

ZMI - 04719872330516 Catalog Number :

Device Description : Self-adhesive electrode package (with magnetic snap) , Black, Each package cont Self-adhesive electrode package (with magnetic snap) , Black, Each package contains dia.55mm (2pcs) + 50mm*90mm (1pcs)

Device Class : 2

Duns Number: 657406062

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

PowerDot - 04719872330592 Catalog Number : PD-01MT

Device Description : PowerDot PD-01MT Muscle Stimulator, Blue

Device Class :

Duns Number: 657406062

Premarket Exempt : No

Product Code : NGX

Prescription Use : No

Device Count : 1

PowerDot - 04719872330622 Catalog Number :

Device Description : Self-adhesive electrode package (with magnetic snap) , Blue, Each package conta Self-adhesive electrode package (with magnetic snap) , Blue, Each package contains electrode dia.55mm (2pcs) + 50mm*90mm (1pcs)

Device Class : 2

Duns Number: 657406062

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

PowerDot - 04719872330639 Catalog Number :

Device Description : Self-adhesive electrode, butterfly type

Device Class : 2

Duns Number: 657406062

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

PowerDot - 04719872330929 Catalog Number :

Device Description : Self-adhesive electrode package (with magnetic snap) , American Flag , Each pac Self-adhesive electrode package (with magnetic snap) , American Flag , Each package contains electrode dia.55mm (2pcs) + 50mm*90mm (1pcs)

Device Class : 2

Duns Number: 657406062

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

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