QMZ · Class II · 21 CFR 882.5705

FDA Product Code QMZ: Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions

A Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions Is A Prescription Device That Is Intended To Provide Stimulation Using A General Purpose Computing Platform To Reduce Sleep Disturbance In Patients Who Experience This Symptom Due To Psychiatric Conditions Such As Nightmare Disorder Or Post Traumatic Stress Disorder (ptsd).

Leading manufacturers include Nightware, Inc..

1
Total
0
Cleared
163d
Avg days
2020
Since

FDA 510(k) Cleared Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions Devices (Product Code QMZ)

1 devices
1–1 of 1
Not Cleared Nov 06, 2020
NightWare Kit, Apple iPhone, Apple Watch, Apple iPhone Charging Cable, Apple Watch Charging Cable
DEN200033
Nightware, Inc.
Neurology · 163d

About Product Code QMZ - Regulatory Context