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REAL Immersive System

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K183296

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 FDA UDI
Model / Reference
REAL1 FDA UDI
Description
REAL Immersive System FDA UDI

Identifiers

Primary DI / UDI-DI
00815948021037 FDA UDI
510(k) Number
K183296 FDA 510(k)FDA UDI
FDA Product Code
ISD FDA 510(k)FDA UDI
GMDN Term
Virtual-display rehabilitation system, non-supportive, clinical FDA UDI

Classification

Device Class
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 890.5360 FDA 510(k)
Regulation Number
890.5360 FDA 510(k)FDA UDI
Advisory Committee
Physical Medicine FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
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

REAL Immersive System by Penumbra, Inc. — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Penumbra, Inc.

Sources (2)

  • FDA 510(k) K183296 24 fields · synced Jun 18, 2026
  • FDA UDI aeac7402-f0e0-4b06-ade2-27c4d8eaa3f7 34 fields · synced May 26, 2026