WELT-i-A

Primary DI

08809548200055

Basic UDI-DI Code

880954820WELT-i-AJJ

Reference

WELT-iP-A

Device Types

None provided

Regulation

Eu Mdr

Classification

Eu Md Class 1

Status

On The Market

Manufacturer

WELT Corp.

Cognitive behavioral therapy for insomnia (CBT-I) is delivered through a user interface implemented in the form of a software. CBT-I that acts on a patient through this product has the major mechanism composed of the followings: sleep restriction therapy to improve sleep efficiency by restricting time in bed (TIB) calculated based on a patient’s real-world data (RWD); sleep hygiene education to intervene in the patient’s behaviors by helping the patient learn a healthy sleep habit and follow principles for sleep quality improvement; stimulus control therapy to reduce the relation between a bedding space and awakening by restricting behaviors other than sleep at the bedding space; cognitive restructuring to reduce anxiety and negative emotions causing insomnia by reconstructing dysfunctional thoughts; and relaxation therapy to reduce tensions and anxiety by inhibiting the sympathetic nerve.

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