BIONESS INC.

Address:25103 RYE CANYON LOOP,Valencia,CA,91355,US

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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

STIMULATOR, NEUROMUSCULAR, EXTERNAL FUNCTIONAL (GZI) (10) Stimulator, muscle, powered (IPF) (3)

Premarket Exempt

No Yes

Clear

L300 Go System - 00815962020498 Catalog Number :

Device Description : Small Quick Fit Electrodes - A

Device Class : 2

Duns Number: 182287727

Premarket Exempt : No

Product Code : GZI, IPF

Prescription Use : Yes

Device Count : 1

L300 Go System - 00815962020504 Catalog Number :

Device Description : Small Quick Fit Electrodes - B

Device Class : 2

Duns Number: 182287727

Premarket Exempt : No

Product Code : GZI, IPF

Prescription Use : Yes

Device Count : 1

H200 Wireless System - 00815962020511 Catalog Number :

Device Description : Cloth Electrodes Set

Device Class : 2

Duns Number: 182287727

Premarket Exempt : No

Product Code : GZI, IPF

Prescription Use : Yes

Device Count : 1

H200 Wireless System - 00815962020528 Catalog Number :

Device Description : H200 Wireless System Kit, Right (Medium)

Device Class : 2

Duns Number: 182287727

Premarket Exempt : No

Product Code : GZI

Prescription Use : Yes

Device Count : 1

H200 Wireless System - 00815962020535 Catalog Number :

Device Description : H200 Wireless System Kit, Left (Medium)

Device Class : 2

Duns Number: 182287727

Premarket Exempt : No

Product Code : GZI

Prescription Use : Yes

Device Count : 1

H200 Wireless System - 00815962020542 Catalog Number :

Device Description : H200 Wireless System Kit, Right (Large)

Device Class : 2

Duns Number: 182287727

Premarket Exempt : No

Product Code : GZI

Prescription Use : Yes

Device Count : 1

H200 Wireless System - 00815962020559 Catalog Number :

Device Description : H200 Wireless System Kit, Left (Large)

Device Class : 2

Duns Number: 182287727

Premarket Exempt : No

Product Code : GZI

Prescription Use : Yes

Device Count : 1

H200 Wireless System - 00815962020566 Catalog Number :

Device Description : H200 Wireless Clinician Kit, Small / Medium

Device Class : 2

Duns Number: 182287727

Premarket Exempt : No

Product Code : GZI

Prescription Use : Yes

Device Count : 1

H200 Wireless System - 00815962020573 Catalog Number :

Device Description : H200 Wireless Clinician Kit, Large

Device Class : 2

Duns Number: 182287727

Premarket Exempt : No

Product Code : GZI

Prescription Use : Yes

Device Count : 1

H200 Wireless System - 00815962020580 Catalog Number :

Device Description : H200 Wireless System Kit, Right (Small)

Device Class : 2

Duns Number: 182287727

Premarket Exempt : No

Product Code : GZI

Prescription Use : Yes

Device Count : 1

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