DeviceClearance

Product code QMZ— Neurology

NightWare Kit, Apple iPhone, Apple Watch, Apple iPhone Charging Cable, Apple Watch Charging Cable

Classification name
Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions
Device class
Class 2
Regulation
21 CFR 882.5705
Advisory panel
Neurology
Total cleared
1
First cleared
Most recent

FDA classification definition

“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).”

— U.S. Food and Drug Administration, device classification record for product code QMZ under 21 CFR 882.5705, via openFDA

Market context for product code QMZ

FDA has cleared 1 device under product code QMZ, all in 2020, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QMZ

Recent clearances under product code QMZ

Data sourced from openFDA. This site is unofficial and independent of the FDA.