# K192474: VERA

- Pathway: 510(k) (Special)
- Applicant: Reflexion Health, Inc.
- Decided: Oct 10, 2019 after 30 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## 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 upper extremity, trunk, and lower extremity with audio-visual feedback & graphic movement representations for patients as well as videos of the patients performing the exercises which can be remotely accessed by the clinician. Patient assessment, exercise guidance and approval by a medical professional is required prior to use.

Source page: https://510kreport.com/device/K192474
Methodology: https://510kreport.com/methodology