PARO Robot V9-14UC

GUDID 04580537541246

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

INTELLIGENT SYSTEM CO.,LTD.

Psychophysiological biofeedback system

• Primary Device ID: 04580537541246
• NIH Device Record Key: b19c1fc7-47d7-49cc-ba83-17cbc661de14
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PARO Robot
• Version Model Number: MCR-900 UC Pink
• Catalog Number: V9-14UC
• Company DUNS: 710958120
• Company Name: INTELLIGENT SYSTEM CO.,LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-847-241-6692
• Email: sales@parorobots.com
• Phone: 1-847-241-6692
• Email: sales@parorobots.com
• Phone: 1-847-241-6692
• Email: sales@parorobots.com
• Phone: 1-847-241-6692
• Email: sales@parorobots.com
• Phone: 1-847-241-6692
• Email: sales@parorobots.com
• Phone: 1-847-241-6692
• Email: sales@parorobots.com
• Phone: 1-847-241-6692
• Email: sales@parorobots.com
• Phone: 1-847-241-6692
• Email: sales@parorobots.com
• Phone: 1-847-241-6692
• Email: sales@parorobots.com
• Phone: 1-847-241-6692
• Email: sales@parorobots.com
• Phone: 1-847-241-6692
• Email: sales@parorobots.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04580537541246 [Primary]

FDA Product Code

• HCC: Device, Biofeedback

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-08
• Device Publish Date: 2020-06-30

On-Brand Devices [PARO Robot]

• 04580537541215: A baby seal type robot with artificial intelligence Neurological Therapeutic Medical Device Biof
• 04580537541246: A baby seal type robot with artificial intelligence in light Pink Color. Neurological Therapeut
• 04580537541239: A baby seal type robot with artificial intelligence in Charcoal Gray Color. Neurological Therap
• 04580537541222: A baby seal type robot with artificial intelligence in Gold Color Neurological Therapeutic Medic