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, muscle, powered (IPF) (3) EXERCISER, POWERED (BXB) (2) STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF) (GZF) (2) AID, TRANSFER (IKX) (1) SYSTEM, ISOKINETIC TESTING AND EVALUATION (IKK) (1)

Premarket Exempt

No Yes

Clear

Bioness Integrated System (BITS)2.0.5 - 00815962020245 Catalog Number :

Device Description : Bioness Integrated Therapy Software

Device Class : 2

Duns Number: 182287727

Premarket Exempt : Yes

Product Code : IKK

Prescription Use : Yes

Device Count : 1

Vector Elite - 00815962020269 Catalog Number :

Device Description : Vector Gait and Safety System

Device Class : 1

Duns Number: 182287727

Premarket Exempt : Yes

Product Code : BXB

Prescription Use : Yes

Device Count : 1

Vector Elite - 00815962020276 Catalog Number :

Device Description : Vector Trolley Assembly, Elite Model

Device Class : 1

Duns Number: 182287727

Premarket Exempt : Yes

Product Code : BXB

Prescription Use : Yes

Device Count : 1

Vector Base - 00815962020283 Catalog Number :

Device Description : Vector Gait and Safety System, Base Model

Device Class : 1

Duns Number: 182287727

Premarket Exempt : Yes

Product Code : IKX

Prescription Use : Yes

Device Count : 1

H200 Wireless - 00815962020290 Catalog Number :

Device Description : Clinician Programmer Software

Device Class : 2

Duns Number: 182287727

Premarket Exempt : No

Product Code : GZI

Prescription Use : Yes

Device Count : 1

StimRouter - 00815962020306 Catalog Number :

Device Description : Clinician Programmer Software

Device Class : 2

Duns Number: 182287727

Premarket Exempt : No

Product Code : GZF

Prescription Use : Yes

Device Count : 1

Bioness StimRouter Extended Hydrogel Electrode Set - 00815962020313 Catalog Number :

Device Description : Extended Hydrogel Electrode Set

Device Class : 2

Duns Number: 182287727

Premarket Exempt : No

Product Code : GZF

Prescription Use : Yes

Device Count : 1

L100 Go System - 00815962020337 Catalog Number :

Device Description : L100 Go System, Right

Device Class : 2

Duns Number: 182287727

Premarket Exempt : No

Product Code : GZI, IPF

Prescription Use : Yes

Device Count : 1

L100 Go System - 00815962020344 Catalog Number :

Device Description : L100 Go System, Left

Device Class : 2

Duns Number: 182287727

Premarket Exempt : No

Product Code : GZI, IPF

Prescription Use : Yes

Device Count : 1

L360 Thigh System - 00815962020382 Catalog Number :

Device Description : L360 Thigh System Kit, Left

Device Class : 2

Duns Number: 182287727

Premarket Exempt : No

Product Code : IPF, GZI

Prescription Use : Yes

Device Count : 1

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