AXIOBIONICS

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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) (9) Electrode, Depth (GZL) (1) Stimulator, Muscle, Powered (IPF) (1) Stimulator, Neuromuscular, External Functional (GZI) (1)

Premarket Exempt

No Yes

Clear

BioGel Velcro Electrode - B367118P20 Catalog Number : 115P

Device Description : Cutaneous Electrode Pair 2” x 2”

Device Class : 2

Duns Number: 033139835

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

BioGel Velcro Electrode - B367119P20 Catalog Number : 119P

Device Description : Cutaneous Electrode Pair 2" x 2.5"

Device Class : 2

Duns Number: 033139835

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

BioGel Velcro Electrode - B367120P20 Catalog Number : 120P

Device Description : Cutaneous Electrode Pair 2” x 3”

Device Class : 2

Duns Number: 033139835

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

OOFS Pace XL Stimulator - B36712159L00 Catalog Number : 12159L

Device Description : Neuromuscular Stimulator

Device Class : 2

Duns Number: 033139835

Premarket Exempt : No

Product Code : IPF, GZI, GZL

Prescription Use : Yes

Device Count : 1

BioGel Velcro Electrode - B367121P20 Catalog Number : 121P

Device Description : Cutaneous Electrode Pair 2" x 3.5"

Device Class : 2

Duns Number: 033139835

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

BioGel Velcro Electrode - B367122P20 Catalog Number : 122P

Device Description : Cutaneous Electrode Pair 2" x 4"

Device Class : 2

Duns Number: 033139835

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

BioGel Velcro Electrode - B367123P20 Catalog Number : 123P

Device Description : Cutaneous Electrode Pair 2" x 5"

Device Class : 2

Duns Number: 033139835

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 1

BioGel Velcro Electrode - B367124P20 Catalog Number : 124P

Device Description : Cutaneous Electrode Pair 2” x 6”

Device Class : 2

Duns Number: 033139835

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

BioGel Velcro Electrode - B367125P20 Catalog Number : 125P

Device Description : Cutaneous Electrode Pair 2” x 8”

Device Class : 2

Duns Number: 033139835

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

BioGel Velcro Electrode - B367126P20 Catalog Number : 126P

Device Description : Cutaneous Electrode Pair 1.5" x 3"

Device Class : 2

Duns Number: 033139835

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

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