IMPULSE MEDICAL TECHNOLOGIES, INC.

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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) (10)

Premarket Exempt

Clear

The Electrode Store - 00816022020908 Catalog Number : FT-3

Device Description : Pre-Gelled Dispos. Ground Electrode/Need Reusable Alligator Clip (100)

Device Class : 2

Duns Number: 080015502

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

The Electrode Store - 00816022020915 Catalog Number : FT-3(10)

Device Description : Pre-Gelled Dispos. Ground Electrode/Need Reusable Alligator Clip (10)

Device Class : 2

Duns Number: 080015502

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

The Electrode Store - 00816022020922 Catalog Number : RE-D(10)

Device Description : Disposable Ring Electrode Strips/Requires Alligator Clip (Sample 10 pack)

Device Class : 2

Duns Number: 080015502

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

The Electrode Store - 00816022020939 Catalog Number : PT30(10)

Device Description : Disposable EMG Bar Electrode; Paired Tabs, (Sample 10 Pack)

Device Class : 2

Duns Number: 080015502

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

The Electrode Store - 00816022020946 Catalog Number : DDA-30

Device Description : Reusable Bar Electrode, Black, Flat 10mm Discs , 30" lead wire; 1.5mm

Device Class : 2

Duns Number: 080015502

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

The Electrode Store - 00816022020953 Catalog Number : SEA-924SAF

Device Description : Reusable Bar Electrode, Paired 9mm Pure Tin Discs, 24" Twist Leads, 1.5mm

Device Class : 2

Duns Number: 080015502

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

The Electrode Store - 00816022020960 Catalog Number : SEA-924GSAF

Device Description : Reusable Bar Electrode, Paired 9mm Gold Plated Discs, 24" Twist Lead,1.5mm

Device Class : 2

Duns Number: 080015502

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

The Electrode Store - 00816022020977 Catalog Number : SEF-924SAF

Device Description : Reusable Bar Electrode, Paired 9mm Steel Discs, Locators, 24" Twist, 1.5mm

Device Class : 2

Duns Number: 080015502

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

The Electrode Store - 00816022020984 Catalog Number : FC-2SAF

Device Description : Two Adult Finger Electrode Clips, 24" Twisted Leads, 1.5 mm sockets

Device Class : 2

Duns Number: 080015502

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

The Electrode Store - 00816022020991 Catalog Number : FC-T-SAF

Device Description : Two Adult Digital Electrode Clips, 24" Twisted Leads, 1.5 mm sockets

Device Class : 2

Duns Number: 080015502

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

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