AXIOBIONICS

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) (10)

Premarket Exempt

No Yes

Clear

BioCollar - B3670030 Catalog Number : 00

Device Description : Cutaneous Electrode Garment

Device Class : 2

Duns Number: 033139835

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

BioCollar - B3670040 Catalog Number : 00

Device Description : Cutaneous Electrode Garment

Device Class : 2

Duns Number: 033139835

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

BioMiniVest - B3670100 Catalog Number : 01

Device Description : Cutaneous Electrode Garment

Device Class : 2

Duns Number: 033139835

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

BioVest - B3670210 Catalog Number : 02

Device Description : Cutaneous Electrode Garment

Device Class : 2

Duns Number: 033139835

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

BioUnitard - B3670320 Catalog Number : 03

Device Description : Cutaneous Electrode Garment

Device Class : 2

Duns Number: 033139835

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

BioMiniBelt - B3670440 Catalog Number : 04

Device Description : Cutaneous Electrode Garment

Device Class : 2

Duns Number: 033139835

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

BioBelt Lumbar - B3670530 Catalog Number : 05

Device Description : Cutaneous Electrode Garment

Device Class : 2

Duns Number: 033139835

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

BioBelt Lumbar Contoured - B3670610 Catalog Number : 06

Device Description : Cutaneous Electrode Garment

Device Class : 2

Duns Number: 033139835

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

BioBelt Ab - B3670700 Catalog Number : 07

Device Description : Cutaneous Electrode Garment

Device Class : 2

Duns Number: 033139835

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

BioBelt Ab Large Expanded - B367080 Catalog Number : 08

Device Description : Cutaneous Electrode Garment

Device Class : 2

Duns Number: 033139835

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

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