# K183296: REAL Immersive System

- Pathway: 510(k) (Traditional)
- Applicant: Penumbra, Inc.
- Decided: Mar 18, 2019 after 111 days
- Product code: ISD (Exerciser, Measuring)
- Device class: 2
- Regulation: 21 CFR 890.5360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K162748 (2017). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162748: MindMotionPRO, Mindmaze SA (2017) Summary page 4.

## Indications for use
The REAL Immersive System is an immersive virtual reality and display system that interactively displays and tracks upper-extremity rehabilitation exercises for adult patients using a combination of virtual environments and full presence tracked avatars for visual feedback. These rehabilitation exercises are intended to be conducted in a seated position in a clinical environment and prescribed and supervised by a medical professional trained in rehabilitation therapy.

Source page: https://510kreport.com/device/K183296
Methodology: https://510kreport.com/methodology