{
  "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": "2026-08-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "Y",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Eligible",
      "product_code": "NRB",
      "openfda": {
        "k_number": [
          "K050129",
          "K140782",
          "K112782",
          "K091038",
          "K122246",
          "K162721",
          "DEN040004",
          "K123980",
          "K131096"
        ],
        "registration_number": [
          "1062240",
          "3004028690",
          "2435119",
          "1928237",
          "1423662",
          "1720929",
          "2183613",
          "3004961578",
          "1424263",
          "3007225330",
          "1450662"
        ],
        "fei_number": [
          "3004028690",
          "3006261799",
          "2435119",
          "1928237",
          "3000215273",
          "1720929",
          "2183613",
          "3004961578",
          "3007225330",
          "1450662",
          "3003015552"
        ]
      },
      "review_panel": "SU",
      "medical_specialty": "SU",
      "device_name": "Wound Cleaner, Ultrasound",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "General, Plastic Surgery",
      "device_class": "2",
      "definition": "The ultrasound wound cleaner/mild debridement system is a device that delivers a cleaning fluid to the wound that is pulsed using low power ultrasound radiation.  The device is intended to clean and mildly debride wounds.  The ultrasound generator must deliver 1.0 mw/cm2 or less energy to the wound",
      "regulation_number": "878.4410",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}