{
  "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
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Ineligible",
      "product_code": "QEF",
      "openfda": {
        "k_number": [
          "DEN170021"
        ],
        "registration_number": [
          "3009769359",
          "3009746061",
          "3017102771",
          "2133810",
          "1000484830"
        ],
        "fei_number": [
          "3009769359",
          "3000203066",
          "3009746061",
          "3017102771",
          "1000484830"
        ]
      },
      "review_panel": "GU",
      "medical_specialty": "GU",
      "device_name": "Pressure Ulcer Management Tool",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Gastroenterology, Urology",
      "device_class": "1",
      "definition": "A pressure ulcer management tool is a prescription device intended for patients at risk of developing pressure ulcers. The device provides output that supports a user’s decision to increase intervention. The device is an adjunct tool for pressure ulcer management that is not intended for detection or diagnostic purposes.",
      "regulation_number": "876.2100",
      "implant_flag": "N",
      "submission_type_id": "4"
    }
  ]
}