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) (7) Stimulator, muscle, powered (IPF) (7) SYSTEM, ISOKINETIC TESTING AND EVALUATION (IKK) (3)

Premarket Exempt

No Yes

Clear

L300 Go System, Left Small Lower Leg - 00815962020146 Catalog Number :

Device Description : L300 Go system with Small Left cuff

Device Class : 2

Duns Number: 182287727

Premarket Exempt : No

Product Code : GZI, IPF

Prescription Use : Yes

Device Count : 1

L300 Go System, Left Thigh Plus - 00815962020153 Catalog Number :

Device Description : L300 Go system with Left Thigh cuff

Device Class : 2

Duns Number: 182287727

Premarket Exempt : No

Product Code : IPF, GZI

Prescription Use : Yes

Device Count : 1

L300 Go System, Left Thigh Stand-Alone - 00815962020160 Catalog Number :

Device Description : L300 Go system with Left Thigh cuff only

Device Class : 2

Duns Number: 182287727

Premarket Exempt : No

Product Code : GZI, IPF

Prescription Use : Yes

Device Count : 1

L300 Go System, Right Lower Leg - 00815962020177 Catalog Number :

Device Description : L300 Go system with Lower Right cuff

Device Class : 2

Duns Number: 182287727

Premarket Exempt : No

Product Code : GZI, IPF

Prescription Use : Yes

Device Count : 1

L300 Go System, Right Small Lower Leg - 00815962020184 Catalog Number :

Device Description : L300 Go system with Small Right cuff

Device Class : 2

Duns Number: 182287727

Premarket Exempt : No

Product Code : IPF, GZI

Prescription Use : Yes

Device Count : 1

L300 Go System, Right Thigh Plus - 00815962020191 Catalog Number :

Device Description : L300 Go system with Right Thigh cuff

Device Class : 2

Duns Number: 182287727

Premarket Exempt : No

Product Code : IPF, GZI

Prescription Use : Yes

Device Count : 1

L300 Go System - 00815962020207 Catalog Number :

Device Description : L300 Go System, Right Thigh Stand-Alone

Device Class : 2

Duns Number: 182287727

Premarket Exempt : No

Product Code : IPF, GZI

Prescription Use : Yes

Device Count : 1

Bioness Integrated System (BITS) Mobile Configuration - 00815962020214 Catalog Number :

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

Device Class : 2

Duns Number: 182287727

Premarket Exempt : Yes

Product Code : IKK

Prescription Use : Yes

Device Count : 1

Bioness Integrated System (BITS)2.0.5 - 00815962020221 Catalog Number :

Device Description : Bioness Integrated Therapy System, Version 2.0, 55" Display with Software

Device Class : 2

Duns Number: 182287727

Premarket Exempt : Yes

Product Code : IKK

Prescription Use : Yes

Device Count : 1

Bioness Integrated System (BITS)2.0.5 - 00815962020238 Catalog Number :

Device Description : Bioness Integrated Therapy System, Version 2.0, 48" Display with Software

Device Class : 2

Duns Number: 182287727

Premarket Exempt : Yes

Product Code : IKK

Prescription Use : Yes

Device Count : 1

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