# DEN200033: NightWare Kit, Apple iPhone, Apple Watch, Apple iPhone Charging Cable, Apple Watch Charging Cable

- Pathway: De Novo (Direct)
- Applicant: Nightware, Inc.
- Decided: Nov 6, 2020 after 163 days
- Product code: QMZ (Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions)
- Device class: 2
- Regulation: 21 CFR 882.5705
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The NightWare digital therapeutic is indicated to provide vibrotactile feedback on an Apple Watch based on an analysis of heart rate and motion during sleep for the temporary reduction of sleep disturbance related to nightmares in adults 22 years or older who suffer from nightmare disorder or have nightmares from posttraumatic stress disorder (PTSD). It is intended for home use.

Source page: https://510kreport.com/device/DEN200033
Methodology: https://510kreport.com/methodology