GEMORE TECHNOLOGY CO., LTD.

Address:11 FL, NO. 29-5, SEC. 2,TAN SHUI Taipei,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

Stimulator, Nerve, Transcutaneous, For Pain Relief (GZJ) (6) Stimulator, Muscle, Powered (IPF) (3) Electrode, Cutaneous (GXY) (2)

Premarket Exempt

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GEM-STIM - 04712832960006 Catalog Number : GM3A50T

Device Description : Physiotherapy Stimulator Analog TENS

Device Class :

Duns Number: 658435078

Premarket Exempt : No

Product Code : GZJ

Prescription Use : Yes

Device Count : 1

GEM-STIM - 04712832960013 Catalog Number : GM3A50E

Device Description : Powered muscle stimulator, Analog EMS

Device Class :

Duns Number: 658435078

Premarket Exempt : No

Product Code : IPF

Prescription Use : Yes

Device Count : 1

GEM-STIM - 04712832960020 Catalog Number : GM3A50TE

Device Description : Analog Combo (TENS+EMS)

Device Class :

Duns Number: 658435078

Premarket Exempt : No

Product Code : IPF, GZJ

Prescription Use : Yes

Device Count : 1

GEM-STIM - 04712832960037 Catalog Number : GM320T(3)

Device Description : Digital TENS

Device Class :

Duns Number: 658435078

Premarket Exempt : No

Product Code : GZJ

Prescription Use : Yes

Device Count : 1

GEM-STIM - 04712832960044 Catalog Number : GM323HV

Device Description : High Voltage Pulsed Galvanic Stimulator

Device Class :

Duns Number: 658435078

Premarket Exempt : No

Product Code : GZJ

Prescription Use : Yes

Device Count : 1

GEM-STIM - 04712832960051 Catalog Number : LW01

Device Description : Lead Wire

Device Class :

Duns Number: 658435078

Premarket Exempt : No

Product Code : GZJ

Prescription Use : No

Device Count : 1

GEM-STIM - 04712832960068 Catalog Number : FA4040

Device Description : Electrode Pad 40x40mm

Device Class :

Duns Number: 658435078

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

GEM-STIM - 04712832960075 Catalog Number : FA5050

Device Description : Electrode Pad 50x50mm

Device Class :

Duns Number: 658435078

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

GEM-STIM - 04712832960198 Catalog Number : GM320PE

Device Description : Digital Pre-program EMS

Device Class :

Duns Number: 658435078

Premarket Exempt : No

Product Code : IPF

Prescription Use : Yes

Device Count : 1

GEM-STIM - 04712832960204 Catalog Number : GM350PP

Device Description : Digital Pre-program TENS

Device Class :

Duns Number: 658435078

Premarket Exempt : No

Product Code : GZJ

Prescription Use : Yes

Device Count : 1

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