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) (2) Stimulator, Neuromuscular, External Functional (GZI) (1)

Premarket Exempt

No Yes

Clear

FreeStep - B3677200 Catalog Number : 72

Device Description : Cutaneous Electrode Garment

Device Class : 2

Duns Number: 033139835

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Bilateral LE BioSleeves - B3677370 Catalog Number : 73

Device Description : Cutaneous Electrode Garment

Device Class : 2

Duns Number: 033139835

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Walkaide - B3677500 Catalog Number : 75

Device Description : Gait-enhancement electrical stimulation system, external

Device Class : 2

Duns Number: 033139835

Premarket Exempt : No

Product Code : GZI

Prescription Use : Yes

Device Count : 1

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