Sleep-Thera

Primary DI

08800300130009

Basic UDI-DI Code

880030013SleepTheraB9

Reference

BELL-001

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 1

Status

On The Market

Manufacturer

Bell Therapeutics Inc.

BELL-001 is a medical device software designed to improve insomnia symptoms using biofeedback therapy systematically applied through a mobile application. The product’s mechanism leverages physiological signals from the user, such as heart rate and breathing patterns, to provide real-time auditory feedback. This feedback guides the user from shallow breathing to stabilized deep breathing through training. The software enhances the parasympathetic nervous system activity, mitigating hyperarousal—the primary cause of insomnia. This process ultimately promotes better sleep by addressing the root causes of sleep disturbances and enhancing the user’s ability to regulate physiological responses.

Other on-the-market devices with the same classification (Eu Md Class 1) and regulation (EU MDR).