IMPULSE MEDICAL TECHNOLOGIES, INC.

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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

Electrode, Cutaneous (GXY) (5) Electrode, Needle (GXZ) (5)

Premarket Exempt

Clear

The Electrode Store - 00816022020427 Catalog Number : SH-96S

Device Description : EEG Single Disc Electrodes, 10mm CAST PURE SILVER/96" COLORED WIRES/(10)

Device Class : 2

Duns Number: 080015502

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

The Electrode Store - 00816022020434 Catalog Number : SH-72S

Device Description : EEG Single Disc Electrodes, 10mm CAST PURE SILVER/72" COLORED WIRES/(10)

Device Class : 2

Duns Number: 080015502

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

The Electrode Store - 00816022020441 Catalog Number : BS-96SAF

Device Description : Dual Button Snap Leads, 96" Twisted Safety Leads

Device Class : 2

Duns Number: 080015502

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

The Electrode Store - 00816022020458 Catalog Number : FC-EZPSAF

Device Description : PEDIATRIC FINGER CLIPS/24"/1.5mm

Device Class : 2

Duns Number: 080015502

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

The Electrode Store - 00816022020465 Catalog Number : SH-120S

Device Description : EEG Single Disc Electrodes, 10mm CAST PURE SILVER/120" COLORED WIRES/(10)

Device Class : 2

Duns Number: 080015502

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

The Electrode Store - 00816022020472 Catalog Number : DTM-1.75SAF(10)

Device Description : Disposable Monopolar Needle Electrodes, 1.75" EMG NEEDLE(PKG/10)

Device Class : 2

Duns Number: 080015502

Premarket Exempt : No

Product Code : GXZ

Prescription Use : No

Device Count : 1

The Electrode Store - 00816022020489 Catalog Number : DTM-2.00SAF

Device Description : Disposable Monopolar EMG Needle Electrodes, 50mm(2") X 26 ga

Device Class : 2

Duns Number: 080015502

Premarket Exempt : No

Product Code : GXZ

Prescription Use : No

Device Count : 1

The Electrode Store - 00816022020496 Catalog Number : DTM-2.00SAF(10)

Device Description : Disposable Monopolar Needle Electrodes, 2.00" EMG NEEDLE(PKG/10)

Device Class : 2

Duns Number: 080015502

Premarket Exempt : No

Product Code : GXZ

Prescription Use : No

Device Count : 1

The Electrode Store - 00816022020502 Catalog Number : DTM-3.00SAF

Device Description : Disposable Monopolar EMG Needle Electrodes, 75mm(3") X 24 ga

Device Class : 2

Duns Number: 080015502

Premarket Exempt : No

Product Code : GXZ

Prescription Use : No

Device Count : 1

The Electrode Store - 00816022020519 Catalog Number : DMD-75(PKG/10)

Device Description : Disposable Monopolar Needle Electrodes, 75mm(3") X 24 ga

Device Class : 2

Duns Number: 080015502

Premarket Exempt : No

Product Code : GXZ

Prescription Use : No

Device Count : 1

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