{
  "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": "2026-10-26",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "proprietary_name": [
        "Portable Neuromodulation Stimulator (PoNS)"
      ],
      "establishment_type": [
        "Manufacture Medical Device",
        "Develop Specifications But Do Not Manufacture At This Facility",
        "Complaint File Establishment per 21 CFR 820.198"
      ],
      "registration": {
        "registration_number": "3015259856",
        "fei_number": "3015259856",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "HELIUS MEDICAL, INC",
        "address_line_1": "642 Newtown Yardley Rd.",
        "address_line_2": "Suite 100",
        "city": "Newtown",
        "state_code": "PA",
        "iso_country_code": "US",
        "zip_code": "18940",
        "postal_code": "",
        "us_agent": {},
        "owner_operator": {
          "firm_name": "Helius Medical, Inc",
          "owner_operator_number": "10059664",
          "official_correspondent": {
            "first_name": "Lawrence",
            "middle_initial": "",
            "last_name": "Picciano",
            "subaccount_company_name": "",
            "phone_number": "x-732-6487332-x"
          },
          "contact_address": {
            "address_1": "642 Newtown Yardley Rd.",
            "address_2": "Suite 100",
            "city": "Newtown",
            "state_code": "PA",
            "state_province": "",
            "iso_country_code": "US",
            "postal_code": "18940"
          }
        }
      },
      "pma_number": "",
      "k_number": "DEN200050",
      "products": [
        {
          "product_code": "QCF",
          "created_date": "2021-04-22",
          "owner_operator_number": "10059664",
          "exempt": "",
          "openfda": {
            "k_number": [
              "DEN200050"
            ],
            "device_name": "Electrical Tongue Stimulator To Treat Motor Deficits",
            "medical_specialty_description": "Neurology",
            "regulation_number": "882.5889",
            "device_class": "2"
          }
        }
      ]
    }
  ]
}