{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "cfres_id": "35278",
      "product_res_number": "Z-0019-05",
      "event_date_initiated": "2004-04-08",
      "event_date_posted": "2004-10-14",
      "recall_status": "Terminated",
      "event_date_terminated": "2004-10-14",
      "res_event_number": "28852",
      "product_code": "JXK",
      "product_description": "HealthPax (HP-1). Cranial Electrotherapy Stimulator",
      "code_info": "HealthPax (HP-1)",
      "firm_fei_number": "2529026",
      "recalling_firm": "Health Directions, Inc",
      "address_1": "81 Big Oak Rd",
      "city": "Morrisville",
      "state": "PA",
      "postal_code": "19067-7801",
      "additional_info_contact": "Harold Stecker, Ph.D.\n215-269-0400",
      "reason_for_recall": "Implied claims (extremes of compulsive or addictive behavior) are outside the scope of clearance for the device",
      "root_cause_description": "Other",
      "action": "The recalling firm issued a letter to their customers dated 4/8/04 informing them of the problem. The letter explained that the manual was changed due to unacceptable text. The consignees were instructed to change the user manuals prior to shipping.",
      "product_quantity": "3475 units",
      "distribution_pattern": "The product was shipped to wholesalers and retailers in CA, MA, NJ, NY, PA, TX, and WA.",
      "openfda": {
        "device_name": "Cranial Electrotherapy Stimulator To Treat Depression",
        "medical_specialty_description": "Neurology",
        "regulation_number": "882.5800",
        "device_class": "3",
        "pma_number": [
          "P230024",
          "P250010"
        ],
        "registration_number": [
          "3040334342",
          "3009493875",
          "3045752358",
          "3019551144",
          "3015088397"
        ],
        "fei_number": [
          "3040334342",
          "3009493875",
          "3045752358",
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}