INTELLIGENT SYSTEM CO.,LTD.

Address:JEC 3F 4316-1,Nanto Toyama,JP

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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

Device, Biofeedback (HCC) (4)

Premarket Exempt

Yes

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PARO Robot - 04580537541215 Catalog Number : V9-14UC

Device Description : A baby seal type robot with artificial intelligenceNeurological Therapeutic Medi A baby seal type robot with artificial intelligenceNeurological Therapeutic Medical DeviceBiofeedback Medical DeviceFor psycho-physiological biofeedback for pain, anxiety, depression, sleep and behavioral issues such as aggression, agitation and wandering, and for rehabilitation of speech, swallowing and fine motor skillsFor patients of dementia, cancer, PTSD, brain injury, Parkinson's disease, etc

Device Class : 2

Duns Number: 710958120

Premarket Exempt : Yes

Product Code : HCC

Prescription Use : Yes

Device Count : 1

PARO Robot - 04580537541222 Catalog Number : V9-14UC

Device Description : A baby seal type robot with artificial intelligence in Gold ColorNeurological Th A baby seal type robot with artificial intelligence in Gold ColorNeurological Therapeutic Medical DeviceBiofeedback Medical DeviceFor psycho-physiological biofeedback for pain, anxiety, depression, sleep and behavioral issues such as aggression, agitation and wandering, and for rehabilitation of speech, swallowing and fine motor skillsFor patients of dementia, cancer, PTSD, brain injury, Parkinson's disease, etc

Device Class : 2

Duns Number: 710958120

Premarket Exempt : Yes

Product Code : HCC

Prescription Use : Yes

Device Count : 1

PARO Robot - 04580537541239 Catalog Number : V9-14UC

Device Description : A baby seal type robot with artificial intelligence in Charcoal Gray Color. Neur A baby seal type robot with artificial intelligence in Charcoal Gray Color. Neurological Therapeutic Medical Device in Biofeedback Medical Device. For psycho-physiological biofeedback for pain, anxiety, depression, sleep and behavioral issues such as aggression, agitation and wandering, and for rehabilitation of speech, swallowing and fine motor skills. For patients of dementia, cancer, PTSD, brain injury, Parkinson's disease, etc

Device Class : 2

Duns Number: 710958120

Premarket Exempt : Yes

Product Code : HCC

Prescription Use : Yes

Device Count : 1

PARO Robot - 04580537541246 Catalog Number : V9-14UC

Device Description : A baby seal type robot with artificial intelligence in light Pink Color. Neurolo A baby seal type robot with artificial intelligence in light Pink Color. Neurological Therapeutic Medical Device in Biofeedback Medical Device. For psycho-physiological biofeedback for pain, anxiety, depression, sleep and behavioral issues such as aggression, agitation and wandering, and for rehabilitation of speech, swallowing and fine motor skills. For patients of dementia, cancer, PTSD, brain injury, Parkinson's disease, etc

Device Class : 2

Duns Number: 710958120

Premarket Exempt : Yes

Product Code : HCC

Prescription Use : Yes

Device Count : 1

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