ZMI ELECTRONICS LTD.

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

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Filters

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

Stimulator, Muscle, Powered, For Muscle Conditioning (NGX) (5) Electrode, Cutaneous (GXY) (3) Equipment, Traction, Powered (ITH) (1) Lamp, Infrared, Therapeutic Heating (ILY) (1)

Premarket Exempt

No Yes

Clear

Mettler - 04719872330035 Catalog Number : MTD4000

Device Description : MTD4000 Traction - Domestic 110V (ME4000)

Device Class : 2

Duns Number: 657406062

Premarket Exempt : No

Product Code : ITH

Prescription Use : No

Device Count : 1

PowerDot - 04719872330318 Catalog Number : PD-01

Device Description : PowerDot PD-01 Muscle Stimulator, Black (with PowerDot Mobile Application)

Device Class :

Duns Number: 657406062

Premarket Exempt : No

Product Code : NGX

Prescription Use : No

Device Count : 1

PowerDot - 04719872330325 Catalog Number : PD-01

Device Description : PowerDot PD-01 Muscle Stimulator, Red (with PowerDot Mobile Application)

Device Class :

Duns Number: 657406062

Premarket Exempt : No

Product Code : NGX

Prescription Use : No

Device Count : 1

PowerDot - 04719872330332 Catalog Number : PD-01

Device Description : PowerDot PD-01 Muscle Stimulator, White (with PowerDot Mobile Application)

Device Class :

Duns Number: 657406062

Premarket Exempt : No

Product Code : NGX

Prescription Use : No

Device Count : 1

PowerDot - 04719872330387 Catalog Number : PD-01M

Device Description : PowerDot PD-01M Muscle Stimulator, Black (with PowerDot Mobile Application)

Device Class :

Duns Number: 657406062

Premarket Exempt : No

Product Code : NGX

Prescription Use : No

Device Count : 1

PowerDot - 04719872330394 Catalog Number : PD-01M

Device Description : PowerDot PD-01M Muscle Stimulator, Red (with PowerDot Mobile Application)

Device Class :

Duns Number: 657406062

Premarket Exempt : No

Product Code : NGX

Prescription Use : No

Device Count : 1

ZMI - 04719872330424 Catalog Number : SAE-MC-R

Device Description : Self-adhesive electrode package (with magnetic snap) , Red, Each package contai Self-adhesive electrode package (with magnetic snap) , Red, Each package contains dia.55mm (4pcs) + 50mm*90mm (2pcs)

Device Class : 2

Duns Number: 657406062

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

ZMI - 04719872330431 Catalog Number : SAE-MC-B

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 (4pcs) + 50mm*90mm (2pcs)

Device Class : 2

Duns Number: 657406062

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

CareWear ® - 04719872330479 Catalog Number :

Device Description : The first wearable, wireless LED light patches for athletes in all sports: on th The first wearable, wireless LED light patches for athletes in all sports: on the training field, on the road, even at home. CareWear Light Patches start relieving pain and accelerating recovery in just 30 minutes.

Device Class :

Duns Number: 657406062

Premarket Exempt : Yes

Product Code : ILY

Prescription Use : No

Device Count : 1

ZMI - 04719872330509 Catalog Number :

Device Class : 2

Duns Number: 657406062

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

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