FDA De Novo · Nightware
DEN200033: NightWare Kit, Apple iPhone, Apple Watch, Apple iPhone Charging Cable, Apple Watch Charging Cable (Nightware, Inc.)
Nightware, Inc. received FDA De Novo DEN200033 for NightWare Kit, Apple iPhone, Apple Watch, Apple iPhone Charging Cable, Apple Watch Charging Cable, with a decision date of Nov 6, 2020.
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | DEN200033 |
|---|---|
| Pathway | De Novo |
| Applicant | Nightware, Inc. |
| Device name | NightWare Kit, Apple iPhone, Apple Watch, Apple iPhone Charging Cable, Apple Watch Charging Cable |
| Product code | QMZ: Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions |
| Regulation (21 CFR) | 882.5705 |
| Device class | Class 2 |
| Date received | May 27, 2020 |
| Decision date | Nov 6, 2020 |
| Decision | Unknown (DENG) |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
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.
Extracted automatically from FDA's decision summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
A De Novo request is for a new type of device with no legally marketed predicate. When FDA grants it, the device can serve as a predicate for later 510(k) submissions.
ChatPPG interpretation
A granted De Novo request authorizes a new type of low- to moderate-risk device and creates a classification regulation for it (here 21 CFR 882.5705). The usual wording is "granted" or "authorized", not "approved". See FDA cleared vs approved.
Product code QMZ is "Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions", class 2, 21 CFR 882.5705. FDA's 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)."
Our labels for filtering: claim Sleep, sensor Wrist PPG. These are heuristics, not FDA fields.