{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-07-27",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
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  "results": [
    {
      "third_party_flag": "N",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Ineligible",
      "product_code": "QMZ",
      "openfda": {
        "k_number": [
          "DEN200033"
        ],
        "registration_number": [
          "3017660607",
          "1424785"
        ],
        "fei_number": [
          "3017660607",
          "3003473212"
        ]
      },
      "review_panel": "NE",
      "medical_specialty": "NE",
      "device_name": "Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Neurology",
      "device_class": "2",
      "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).",
      "regulation_number": "882.5705",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}