# K981969: Ultima Body Position Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Braebon Medical Corp.
- Decided: Aug 20, 1998 after 77 days
- Product code: LEL (Device, Sleep Assessment)
- Device class: 2
- Regulation: 21 CFR 882.5050
- 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 K923033 (1993). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940013: Body Position Indicator, Model BPI1, Pro-Tech, Inc. (1995) Summary page 3.
- K923033: The Tracker, Epm Information Systems, Inc. (1993) Summary page 3.

## Most influential descendants
- K191492: Maxxi Position Sensor (2020), 0 descendants of its own

## Indications for use
The BRAEBON MEDICAL CORPORATION Ultima Body Position Sensor™ is intended for use during sleep disorder studies as an indicator of body position. The sensor uses a three-volt lithium battery and plugs directly into either a DC amplifier or multiplexer. The target population of the Ultima Body Position Sensor is all children and adult patients who are screened during sleep disorder studies. The majority of the screenings occur at a sleep laboratory although the sensor can also be used in home studies. The Ultima Body Position Sensor is intended for use only by or on the order of a physician. The Ultima Body Position Sensor is similar in design, function and intent as the legally marketed Sleep Position Indicator, Model BPI1, k940013; Mini-Tracker, k923033.

Source page: https://510kreport.com/device/K981969
Methodology: https://510kreport.com/methodology