# K150462: Vera

- Pathway: 510(k) (Traditional)
- Applicant: Reflexion Health, Inc.
- Decided: Oct 30, 2015 after 249 days
- Product code: LXJ (Interactive Rehabilitation Exercise Devices)
- 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: 4 generations back to K890076 (1989). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130847: Jintronix Rehabilitation System (JRS), Jintronix, Inc. (2014) Summary page 4.

## Indications for use
A software system used with the Microsoft Kinect v2 intended to support the physical rehabilitation of adults in the clinic and at home. The system includes rehabilitation exercises for the lower extremity with audio-visual feedback & graphic movement representations for patients as well as remotely accessible patient performance video. Patient assessment, exercise guidance and approval by a medical professional is required prior to use.

Source page: https://510kreport.com/device/K150462
Methodology: https://510kreport.com/methodology