Identity
- Trade Name
- REAL y-Series FDA UDI
- Generic Name
- Mental health/function therapeutic software, virtual reality FDA UDI
- Device Name
- REAL y-Series 2 FDA UDI
- Model / Reference
- RLY2-A FDA UDI
- Description
- REAL y-Series 2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815948029460 FDA UDI
- 510(k) Number
- K183296 FDA UDI
- FDA Product Code
- ISD FDA UDI
- GMDN Term
- Mental health/function therapeutic software, virtual reality FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5360 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Virtual-display rehabilitation system, non-supportive, clinicalMental health/function therapeutic software, virtual reality
REAL y-Series by Penumbra, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Mental health/function therapeutic software, virtual reality.
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- REAL y-Series — PENUMBRA, INC. · Class II
Cleared under the same submission
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 |
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Manufacturer
- Manufacturer
- Penumbra, Inc.
Sources (1)
- FDA UDI 7059dfb3-5d69-4ecf-8bee-05769abdc285 34 fields · synced May 29, 2026