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) (10)

Premarket Exempt

No Yes

Clear

NESS H200® Wireless Hand Rehabilitation System - 07290110482046 Catalog Number : 501-00094-01

Device Description : H200 Wireless (US) Clinician Kit, Small / Medium

Device Class : 2

Duns Number: 182287727

Premarket Exempt : No

Product Code : IPF

Prescription Use : Yes

Device Count : 1

NESS H200® Wireless Hand Rehabilitation System - 07290110482053 Catalog Number : 501-00095-01

Device Description : H200 Wireless US Clinician Kit Large

Device Class : 2

Duns Number: 182287727

Premarket Exempt : No

Product Code : IPF

Prescription Use : Yes

Device Count : 1

NESS H200® Wireless Hand Rehabilitation System - 07290110482060 Catalog Number : 501-00120-01

Device Description : H200 Wireless US System kit, Right Small

Device Class : 2

Duns Number: 182287727

Premarket Exempt : No

Product Code : IPF

Prescription Use : Yes

Device Count : 1

NESS H200® Wireless Hand Rehabilitation System - 07290110482077 Catalog Number : 501-00121-01

Device Description : H200 Wireless US System kit, Left Small

Device Class : 2

Duns Number: 182287727

Premarket Exempt : No

Product Code : IPF

Prescription Use : Yes

Device Count : 1

NESS H200® Wireless Hand Rehabilitation System - 07290110482084 Catalog Number : 501-00176-01

Device Description : H200 Wireless US Clinician Upgrade Kit

Device Class : 2

Duns Number: 182287727

Premarket Exempt : No

Product Code : IPF

Prescription Use : Yes

Device Count : 1

NESS L300-Plus System - 07290110483005 Catalog Number : 501-00122-01

Device Description : L300 Plus US System Kit, Left (regular)

Device Class : 2

Duns Number: 182287727

Premarket Exempt : No

Product Code : IPF

Prescription Use : Yes

Device Count : 1

NESS L300-Plus System - 07290110483012 Catalog Number : 501-00123-01

Device Description : L300 Plus US System Kit, Right (regular)

Device Class : 2

Duns Number: 182287727

Premarket Exempt : No

Product Code : IPF

Prescription Use : Yes

Device Count : 1

NESS L300-Plus System - 07290110483029 Catalog Number : 501-00126-01

Device Description : L300 Plus US Upgrade System Kit, Left (regular)

Device Class : 2

Duns Number: 182287727

Premarket Exempt : No

Product Code : IPF

Prescription Use : Yes

Device Count : 1

NESS L300-Plus System - 07290110483036 Catalog Number : 501-00127-01

Device Description : L300 Plus US Upgrade System Kit, Right (regular)

Device Class : 2

Duns Number: 182287727

Premarket Exempt : No

Product Code : IPF

Prescription Use : Yes

Device Count : 1

NESS L300-Plus System - 07290110483043 Catalog Number : 501-00046-01

Device Description : L300 Plus US Clinician's Upgrade Kit

Device Class : 2

Duns Number: 182287727

Premarket Exempt : No

Product Code : IPF

Prescription Use : Yes

Device Count : 1

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