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) (4) STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF) (GZF) (4) Stimulator, muscle, powered (IPF) (4) SYSTEM, ISOKINETIC TESTING AND EVALUATION (IKK) (2)

Premarket Exempt

No Yes

Clear

StimRouter Implantable Kit - 00815962020016 Catalog Number :

Device Description : StimRouter Implantable Lead

Device Class : 2

Duns Number: 182287727

Premarket Exempt : No

Product Code : GZF

Prescription Use : Yes

Device Count : 1

StimRouter Clinician's Kit - 00815962020023 Catalog Number :

Device Description : Clinician’s Programmer with Software

Device Class : 2

Duns Number: 182287727

Premarket Exempt : No

Product Code : GZF

Prescription Use : Yes

Device Count : 1

StimRouter User Kit - 00815962020030 Catalog Number :

Device Description : External Pulse Transmitter (EPT)

Device Class : 2

Duns Number: 182287727

Premarket Exempt : No

Product Code : GZF

Prescription Use : Yes

Device Count : 1

StimRouter Electrode Set - 00815962020047 Catalog Number :

Device Description : Electrode Set

Device Class : 2

Duns Number: 182287727

Premarket Exempt : No

Product Code : GZF

Prescription Use : Yes

Device Count : 1

Bioness Integrated System (BITS)2.0.5 - 00815962020054 Catalog Number :

Device Class : 2

Duns Number: 182287727

Premarket Exempt : Yes

Product Code : IKK

Prescription Use : Yes

Device Count : 1

L300 Go Clinician Programmer Software - 00815962020061 Catalog Number :

Device Description : Clinician Programmer Software for L300 Go system

Device Class : 2

Duns Number: 182287727

Premarket Exempt : No

Product Code : GZI, IPF

Prescription Use : Yes

Device Count : 1

Bioness L300 Go Hydrogel Electrodes Set - 00815962020078 Catalog Number :

Device Description : Hydrogel Electrode Set

Device Class : 2

Duns Number: 182287727

Premarket Exempt : No

Product Code : IPF, GZI

Prescription Use : Yes

Device Count : 1

L300 Go Clinician Kit - 00815962020115 Catalog Number :

Device Description : L300 Go Accessories

Device Class : 2

Duns Number: 182287727

Premarket Exempt : No

Product Code : GZI, IPF

Prescription Use : Yes

Device Count : 1

Bioness Integrated System (BITS) Bedside Configuration - 00815962020122 Catalog Number :

Device Description : Bioness Integrated Therapy System, Version 2.0, Bedside Configuration, 24" Displ Bioness Integrated Therapy System, Version 2.0, Bedside Configuration, 24" Display with Software

Device Class : 2

Duns Number: 182287727

Premarket Exempt : Yes

Product Code : IKK

Prescription Use : Yes

Device Count : 1

L300 Go System, Left Lower Leg - 00815962020139 Catalog Number :

Device Description : L300 Go system with Lower Left cuff

Device Class : 2

Duns Number: 182287727

Premarket Exempt : No

Product Code : IPF, GZI

Prescription Use : Yes

Device Count : 1

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