ROCHESTER ELECTRO-MEDICAL, 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) (10)

Premarket Exempt

No Yes

Clear

EverLast™ - 10816843020818 Catalog Number :

Device Description : REUSABLE EVERLAST CUP ELECTRODES: 9 MM MOLDED GOLD DISC, 8 FT. (2.5 M), RIBBON, REUSABLE EVERLAST CUP ELECTRODES: 9 MM MOLDED GOLD DISC, 8 FT. (2.5 M), RIBBON, PVC WIRE W/ QUICK DISCONNECT

Device Class : 2

Duns Number: 068156330

Premarket Exempt : Yes

Product Code : GXY

Prescription Use : Yes

Device Count : 1

EverLast™ - 10816843020832 Catalog Number :

Device Description : REUSABLE EVERLAST CUP ELECTRODES: 9 MM MOLDED SILVER DISC, 6 FT. (1.8 M), SINGLE REUSABLE EVERLAST CUP ELECTRODES: 9 MM MOLDED SILVER DISC, 6 FT. (1.8 M), SINGLE, SILICONE WIRE

Device Class :

Duns Number: 068156330

Premarket Exempt : Yes

Product Code : GXY

Prescription Use : Yes

Device Count : 5

EverLast™ - 10816843020856 Catalog Number :

Device Description : REUSABLE EVERLAST CUP ELECTRODES: 9 MM MOLDED GOLD DISC, 4 FT. (1.2 M), SINGLE, REUSABLE EVERLAST CUP ELECTRODES: 9 MM MOLDED GOLD DISC, 4 FT. (1.2 M), SINGLE, SILICONE WIRE

Device Class :

Duns Number: 068156330

Premarket Exempt : Yes

Product Code : GXY

Prescription Use : Yes

Device Count : 5

EverLast™ - 10816843020870 Catalog Number :

Device Description : REUSABLE EVERLAST CUP ELECTRODES: 9 MM MOLDED GOLD DISC, 6 FT. (1.8 M), SINGLE, REUSABLE EVERLAST CUP ELECTRODES: 9 MM MOLDED GOLD DISC, 6 FT. (1.8 M), SINGLE, SILICONE WIRE

Device Class :

Duns Number: 068156330

Premarket Exempt : Yes

Product Code : GXY

Prescription Use : Yes

Device Count : 5

EverLast™ - 10816843020894 Catalog Number :

Device Description : REUSABLE EVERLAST CUP ELECTRODES: 9 MM MOLDED SILVER DISC, 8 FT. (2.5 M), SINGLE REUSABLE EVERLAST CUP ELECTRODES: 9 MM MOLDED SILVER DISC, 8 FT. (2.5 M), SINGLE, SILICONE WIRE

Device Class :

Duns Number: 068156330

Premarket Exempt : Yes

Product Code : GXY

Prescription Use : Yes

Device Count : 5

EverLast™ - 10816843020917 Catalog Number :

Device Description : REUSABLE EVERLAST CUP ELECTRODES: 6 MM STAMPED TIN DISC, 3 FT. (0.9 M), RIBBON, PVC WIRE

Device Class : 2

Duns Number: 068156330

Premarket Exempt : Yes

Product Code : GXY

Prescription Use : Yes

Device Count : 1

EverLast™ - 10816843020931 Catalog Number :

Device Description : REUSABLE EVERLAST CUP ELECTRODES: 6 MM STAMPED TIN DISC, 4 FT. (1.2 M), RIBBON, PVC WIRE

Device Class : 2

Duns Number: 068156330

Premarket Exempt : Yes

Product Code : GXY

Prescription Use : Yes

Device Count : 1

EverLast™ - 10816843020955 Catalog Number :

Device Description : REUSABLE EVERLAST CUP ELECTRODES: 9 MM STAMPED TIN DISC, 4 FT. (1.2 M), RIBBON, PVC WIRE

Device Class : 2

Duns Number: 068156330

Premarket Exempt : Yes

Product Code : GXY

Prescription Use : Yes

Device Count : 1

EverLast™ - 10816843020979 Catalog Number :

Device Description : REUSABLE EVERLAST CUP ELECTRODES: 9 MM STAMPED TIN DISC, 5 FT. (1.5 M), RIBBON, PVC WIRE

Device Class : 2

Duns Number: 068156330

Premarket Exempt : Yes

Product Code : GXY

Prescription Use : Yes

Device Count : 1

EverLast™ - 10816843020993 Catalog Number :

Device Description : REUSABLE EVERLAST CUP ELECTRODES: 9 MM STAMPED TIN DISC, 6 FT. (1.8 M), RIBBON, PVC WIRE

Device Class : 2

Duns Number: 068156330

Premarket Exempt : Yes

Product Code : GXY

Prescription Use : Yes

Device Count : 1

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