# K191492: Maxxi Position Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Neurovirtual USA, Inc.
- Decided: Apr 24, 2020 after 324 days
- Product code: GWQ (Full-Montage Standard Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K923033 (1993). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131335: Bwmini Eeg, Bwminihst, Bwmini PSG, Neurovirtual USA, Inc. (2015) Summary page 4.
- K981969: Ultima Body Position Sensor, Braebon Medical Corp. (1998) Summary page 4.
- K923033: The Tracker, Epm Information Systems, Inc. (1993) Summary page 5.

## Indications for use
The Maxxi Position Sensor is intended for use with the BWMini polysomnograph system, to acquire the body position of adult patients during sleep studies. The Sensor produces signals for five positions: standing/sitting, supine, prone, left and right. It is intended for use in research, home sleep studies, ambulatory, and clinical environments.

Source page: https://510kreport.com/device/K191492
Methodology: https://510kreport.com/methodology