Identity
- Trade Name
- PARO Robot FDA UDI
- Generic Name
- Psychophysiological biofeedback system FDA UDI
- Device Name
- A baby seal type robot with artificial intelligence in Gold Color Neurological Therapeutic Medical Device 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 FDA UDI
- Model / Reference
- MCR-900 UC Gold FDA UDI
- Description
- A baby seal type robot with artificial intelligence in Gold Color Neurological Therapeutic Medical Device 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 FDA UDI
Identifiers
- Catalog Number
- V9-14UC FDA UDI
- Primary DI / UDI-DI
- 04580537541222 FDA UDI
- FDA Product Code
- HCC FDA UDI
- GMDN Term
- Psychophysiological biofeedback system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Psychophysiological biofeedback system
PARO Robot by Intelligent System Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Psychophysiological biofeedback system.
- Axon — EXSURGO LIMITED · Class II
- TT-EEG MONO/BIPOLAR ELECTRODE KIT — Thought Technology Ltd. · Class II
- DC-EEG TWO CHANNEL CONNECTIVIT KIT — Thought Technology Ltd. · Class II
- dorsaVi — DORSAVI LTD · Class II
- Switch Sensor Cable — Thought Technology Ltd. · Class II
- Flexcomp Infiniti Encoder — Thought Technology Ltd. · Class II
- Trigno Avanti Mini Sensor — DELSYS, INC. · Class II
- Pathway — PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Intelligent System Co., Ltd.
Sources (1)
- FDA UDI 8cecf952-ef9d-4a86-9e76-f3be96bf320b 35 fields · synced May 30, 2026