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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 threevolt lithium battery and plugs directly into either a DC amplifier or multiplexer.

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 threevolt lithium battery and plugs directly into either a DC amplifier or multiplexer.

This document is a 510(k) clearance letter from the FDA for the Ultima Body Position Sensor. It confirms substantial equivalence to predicate devices but does not contain information about acceptance criteria, study design, or performance data. Therefore, I cannot generate the requested table or answer most of the questions.

The document states:

• Device Name: Ultima Body Position Sensor
• Indications For Use: Intended for use during sleep disorder studies as an indicator of body position in children and adult patients.
• Predicate Devices: Sleep Position Indicator, Model BPI1, K940013; Mini-Tracker, K923033.

Since the provided document is an FDA clearance letter and not a study report, it does not contain the detailed information necessary to complete the requested table and answer the study-related questions.

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