{
  "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": "2026-09-14",
    "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": "SDO",
      "openfda": {
        "k_number": [
          "DEN240014",
          "K253638",
          "K252893",
          "K251821"
        ],
        "registration_number": [
          "3034209955",
          "3045321552",
          "3034211447",
          "3027062639"
        ],
        "fei_number": [
          "3034209955",
          "3045321552",
          "3034211447",
          "3027062639"
        ]
      },
      "review_panel": "PM",
      "medical_specialty": "PM",
      "device_name": "Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Physical Medicine",
      "device_class": "2",
      "definition": "A transcutaneous electrical spine stimulator to improve skeletal muscle strength and sensation is a device that can be programmed to apply an electrical current via electrodes on a patient's skin over the spine to improve muscle strength and sensation after neurological deficit.",
      "regulation_number": "890.5851",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}