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510(k) DEN200033

NightWare Kit, Apple iPhone, Apple Watch, Apple iPhone Charging Cable, Apple Watch Charging Cable by Nightware, Inc. — Product Code QMZ

DEN200033 is an FDA 510(k) premarket notification submitted by Nightware, Inc. for the device "NightWare Kit, Apple iPhone, Apple Watch, Apple iPhone Charging Cable, Apple Watch Charging Cable". The FDA issued a decision of De Novo Granted on November 6, 2020. The device falls under product code QMZ (Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions), a Class II device regulated under 21 CFR 882.5705.

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
November 6, 2020
Date Received
May 27, 2020
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions
Device Class
Class II
Regulation Number
882.5705
Review Panel
NE
Submission Type

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).

FDA data resources