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, muscle, powered (IPF) (5)

Premarket Exempt

No Yes

Clear

NESS L300 Foot Drop System - 07290110483050 Catalog Number : 501-00158-01

Device Description : Regular L300 System Kit, Left US

Device Class : 2

Duns Number: 182287727

Premarket Exempt : No

Product Code : IPF

Prescription Use : Yes

Device Count : 1

NESS L300 Foot Drop System - 07290110483067 Catalog Number : 501-00159-01

Device Description : Regular L300 System Kit, Right US

Device Class : 2

Duns Number: 182287727

Premarket Exempt : No

Product Code : IPF

Prescription Use : Yes

Device Count : 1

NESS L300 Foot Drop System - 07290110483074 Catalog Number : 501-00161-01

Device Description : Regular L300 Clinician's Kit US

Device Class : 2

Duns Number: 182287727

Premarket Exempt : No

Product Code : IPF

Prescription Use : Yes

Device Count : 1

NESS L300 Foot Drop System - 07290110483081 Catalog Number : 501-00169-01

Device Description : Small L300 System Kit, Left US

Device Class : 2

Duns Number: 182287727

Premarket Exempt : No

Product Code : IPF

Prescription Use : Yes

Device Count : 1

NESS L300 Foot Drop System - 07290110483098 Catalog Number : 501-00170-01

Device Description : Small L300 System Kit, Right US

Device Class : 2

Duns Number: 182287727

Premarket Exempt : No

Product Code : IPF

Prescription Use : Yes

Device Count : 1

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