Duns Number:710958120
Device Description: A baby seal type robot with artificial intelligence in Charcoal Gray Color. Neurological T 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
Catalog Number
V9-14UC
Brand Name
PARO Robot
Version/Model Number
MCR-900 UC Charcoal Gray
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HCC
Product Code Name
Device, Biofeedback
Public Device Record Key
b5d94990-37b5-4762-a289-bc4de836050c
Public Version Date
July 08, 2020
Public Version Number
1
DI Record Publish Date
June 30, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |