{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "65660",
      "product_res_number": "Z-0712-2008",
      "event_date_initiated": "2007-10-29",
      "event_date_posted": "2008-04-08",
      "recall_status": "Terminated",
      "event_date_terminated": "2011-09-21",
      "res_event_number": "45503",
      "product_code": "JXK",
      "k_numbers": [
        "K062284"
      ],
      "product_description": "CES Ultra, Cranial Electrotherapy Stimulator, Serial Numbers: 1000 through  3999, Manufactured by Arco Electronics Limited, Distributed by Neuro-Fitness LLC, Fall City, Washington 98024",
      "code_info": "Serial Numbers: 1000 through 3999.",
      "firm_fei_number": "3005026995",
      "recalling_firm": "Neuro-Fitness LLC",
      "address_1": "33631 #2 Redmond-Fall City Rd.",
      "city": "Fall City",
      "state": "WA",
      "postal_code": "98024",
      "additional_info_contact": "Michael Stevens\n425-821-4968",
      "reason_for_recall": "No FDA clearance for the .35Hz/.45Hz frequency option on device.",
      "root_cause_description": "Finished device change control",
      "action": "Consignees were notified of this recall by an Urgent Device Recall Letter sent via U.S. First Class mail on 10/29/07.  The letter instructs users to contact the recalling firm to make arrangements to return the device.  The letter also instructs users to return an enclosed response card.  Consignees who do not respond will receive a follow-up telephone call two weeks after initial mailing of recall notice.  For more information, contact firm at 1-866-937-4237.",
      "product_quantity": "3,000 units",
      "distribution_pattern": "Worldwide Distribution",
      "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": [
          "3015088397",
          "3045752358",
          "3019551144",
          "3009493875",
          "3040334342"
        ],
        "fei_number": [
          "3015088397",
          "3045752358",
          "3019551144",
          "3009493875",
          "3040334342"
        ]
      }
    }
  ]
}