{
  "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",
      "city": "Shenzhen",
      "advisory_committee_description": "Cardiovascular",
      "address_1": "1st Bldg.,501-1&501-2,Mitehua&Pukyo Bio Science Park",
      "address_2": "Jinxiu E. Rd.,Laokeng Comm.,Longtian St.,Pings Dist.",
      "statement_or_summary": "Summary",
      "product_code": "MWJ",
      "openfda": {
        "registration_number": [
          "3012528160",
          "3008717264",
          "3009443693",
          "1126271",
          "3010552191",
          "3016406615",
          "3006087789",
          "3013500228",
          "3010844918",
          "3010082909",
          "3010390468",
          "9610816",
          "3014848734",
          "1000122786",
          "1000165971",
          "3032906215",
          "3008159616",
          "1224919",
          "2028530",
          "3007184699",
          "3013889955",
          "3016701404",
          "3043479346",
          "3007770164",
          "9681548",
          "3008413470",
          "3004035727",
          "3004009431",
          "3010381606",
          "3017446092",
          "2133641",
          "9611295",
          "1316463",
          "3009077524",
          "3013596024",
          "3010222749",
          "3015185344",
          "8030978",
          "3035371769",
          "1218950",
          "3004006614",
          "3016618143",
          "3012027770",
          "3014235520",
          "3008977358",
          "3015529350",
          "3010157426",
          "3011883032",
          "1527715",
          "3003971136",
          "3009499478"
        ],
        "fei_number": [
          "3012528160",
          "3008717264",
          "3002807992",
          "3009443693",
          "3016406615",
          "3006087789",
          "3013500228",
          "1000125122",
          "3010844918",
          "3010082909",
          "3010390468",
          "3002808182",
          "3000203466",
          "3014848734",
          "1000122786",
          "3002807745",
          "1000165971",
          "3008159616",
          "3032906215",
          "3007184699",
          "3013889955",
          "3016701404",
          "3043479346",
          "3007770164",
          "3008413470",
          "3004035727",
          "3004009431",
          "3010381606",
          "3017446092",
          "1316463",
          "3009077524",
          "3013596024",
          "3010222749",
          "3015185344",
          "3035371769",
          "1218950",
          "3004006614",
          "1000263641",
          "3016618143",
          "3012027770",
          "3014235520",
          "3008977358",
          "3015529350",
          "1000513706",
          "3010157426",
          "3011883032",
          "1527715",
          "3015191855",
          "3002807167",
          "3003971136",
          "3009499478"
        ],
        "device_name": "Electrocardiograph, Ambulatory (Without Analysis)",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.2800",
        "device_class": "2"
      },
      "zip_code": "518122",
      "applicant": "Shenzhen Xinyan Medical Technology Co.,ltd.",
      "decision_date": "2026-09-11",
      "decision_code": "SESE",
      "country_code": "CN",
      "device_name": "Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable ECG Recorder (YMHeart XY-1202); Wearable ECG Recorder (YMHeart XY-1203); Wearable ECG Recorder (YMHeart XY-03); Wearable ECG Recorder (YMHeart XY-0301); Wearable ECG Recorder (YMHeart XY-0302); Wearable ECG Recorder (YMHeart XY-0303)",
      "advisory_committee": "CV",
      "contact": "Zhang  Haibo",
      "expedited_review_flag": "",
      "k_number": "K254119",
      "state": "",
      "date_received": "2025-12-19",
      "review_advisory_committee": "CV",
      "postal_code": "518122",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}