# K971079: Interlogics W-Tracker and Wrist Works Software

- Pathway: 510(k) (Traditional)
- Applicant: Interlogics, Inc.
- Decided: Jul 9, 1997 after 106 days
- Product code: KQX (Goniometer, Ac-Powered)
- Device class: 1
- Regulation: 21 CFR 888.1500
- 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
The W-Tracker is a bi-axial wrist-joint movement assessment device mounted on a forearm and hand. Specifically, it measures angular range of motion and velocity in two planes. The Clinical Analysis protocol requires the subject to perform a series of wrist movements, including wrist flexion/extension and ulnar/radial deviation, each to be performed by the subject at his/her preferred speed. The data obtained during the Clinical Analysis protocol is real-time data, and is immediately transferred from the W-Tracker to the computer via an A/D conversion device to a serial port. The goals of the device when performing the Clinical Analysis protocol is to compile information related to tests devised by the AMA to measure impairment of wrist joints, and to compare performance profiles of normal and injured populations. The W-Tracker does not initiate or control any movement during a test and it does not induce any forces on the subject. It is, therefore, a passive device. The only forces acting on the subject are the negligible inertial forces of the W-Tracker generated by the subject’s wrist movements. The device is fail-safe in design to obviate safety concerns for the subject.

Source page: https://510kreport.com/device/K971079
Methodology: https://510kreport.com/methodology