{
  "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": "2026-06-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Carmel",
      "advisory_committee_description": "Physical Medicine",
      "address_1": "11460 N.Meridian St.,",
      "address_2": "Suite 150",
      "statement_or_summary": "Summary",
      "product_code": "IKT",
      "openfda": {
        "registration_number": [
          "3004040397",
          "3013557562",
          "1067162",
          "3007481893",
          "3005581220",
          "3013501110",
          "9611252",
          "1045254",
          "3013298431",
          "3010805941",
          "1048735",
          "3008892509",
          "3006697681",
          "2029275",
          "3009171251",
          "3010611950",
          "9610691",
          "2022388",
          "3008252486",
          "3008617703",
          "9612501",
          "1063285",
          "3018094310",
          "8020864",
          "3010173425",
          "9710376",
          "3005941719",
          "3012494290",
          "3014479313",
          "3005581270",
          "3010220595",
          "3009756327",
          "3016852448",
          "3030733800",
          "2080783",
          "2953359",
          "3006849754",
          "9710582",
          "3017210488"
        ],
        "fei_number": [
          "3003495548",
          "3004040397",
          "3013557562",
          "3000215205",
          "3003831320",
          "3007481893",
          "3005581220",
          "3013501110",
          "3002807038",
          "1045254",
          "3006759904",
          "3002807111",
          "3013298431",
          "1000306431",
          "3010805941",
          "3002806359",
          "3005737257",
          "1048735",
          "3008892509",
          "3002807720",
          "1000403400",
          "3006697681",
          "3010611950",
          "3003514332",
          "2022388",
          "3008617703",
          "3018094310",
          "3001450493",
          "3012494290",
          "3014479313",
          "3002807036",
          "3005581270",
          "3010220595",
          "3016852448",
          "3030733800",
          "2080783",
          "3006849754",
          "3008252486",
          "3017210488"
        ],
        "device_name": "Electrode, Needle, Diagnostic Electromyograph",
        "medical_specialty_description": "Physical Medicine",
        "regulation_number": "890.1385",
        "device_class": "2"
      },
      "zip_code": "46032",
      "applicant": "Bionen S.A.S.",
      "decision_date": "2010-10-07",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR NEEDLE",
      "advisory_committee": "PM",
      "contact": "Allison  Scott",
      "expedited_review_flag": "",
      "k_number": "K092973",
      "state": "IN",
      "date_received": "2009-09-25",
      "review_advisory_committee": "NE",
      "postal_code": "46032",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}