{
  "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": "2026-07-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Rockville",
      "advisory_committee_description": "Physical Medicine",
      "address_1": "12300 Twinbrook Pkwy., Suite 625",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "IMI",
      "openfda": {
        "registration_number": [
          "3014980461",
          "9612147",
          "3017264244",
          "3010280625",
          "8010720",
          "3010362721",
          "3013917867",
          "3012316249",
          "3011767724",
          "3009155917",
          "3013069546",
          "3009437400",
          "3033524168",
          "3037609256",
          "3005170249",
          "1313525",
          "1648700",
          "3030151584",
          "2013558",
          "2011115",
          "3014315574",
          "9616086",
          "3004167969"
        ],
        "fei_number": [
          "3014980461",
          "3017264244",
          "3006076154",
          "3010280625",
          "3010362721",
          "3000204260",
          "3013917867",
          "3012316249",
          "3011767724",
          "3009155917",
          "3013069546",
          "3009437400",
          "7759",
          "3033524168",
          "3037609256",
          "3005170249",
          "3002806913",
          "1317628",
          "3030151584",
          "2013558",
          "2011115",
          "3014315574",
          "3004167969"
        ],
        "device_name": "Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat",
        "medical_specialty_description": "Physical Medicine",
        "regulation_number": "890.5300",
        "device_class": "2"
      },
      "zip_code": "20852",
      "applicant": "C.L. Mcintosh & Assoc., Inc.",
      "decision_date": "1997-06-16",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "ORTHOSONICS DUO-SON ULTRASOUND DIATHERMY DEVICE",
      "advisory_committee": "PM",
      "contact": "T. WHIT  ATHEY, PH.D.",
      "expedited_review_flag": "",
      "k_number": "K970131",
      "state": "MD",
      "date_received": "1997-01-14",
      "review_advisory_committee": "PM",
      "postal_code": "20852",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}