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REAL Immersive System

FDA UDI

Class II (US FDA UDI)

by Penumbra, Inc.

Identity

Trade Name
REAL Immersive System FDA UDI
Generic Name
Virtual-display rehabilitation system, non-supportive, clinical FDA UDI
Device Name
REAL Immersive System, Eval Use FDA UDI
Model / Reference
REAL1V-A FDA UDI
Description
REAL Immersive System, Eval Use FDA UDI

Identifiers

Primary DI / UDI-DI
00815948024205 FDA UDI
510(k) Number
K183296 FDA UDI
FDA Product Code
ISD FDA UDI
GMDN Term
Virtual-display rehabilitation system, non-supportive, clinical 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

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Virtual-display rehabilitation system, non-supportive, clinical

REAL Immersive System by Penumbra, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Virtual-display rehabilitation system, non-supportive, clinical.

Cleared under the same submission

K183296 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Penumbra, Inc.

Sources (1)

  • FDA UDI 640513c3-0148-46ed-8008-28bb76659dfd 34 fields · synced Jun 8, 2026