{
  "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": "2026-08-31",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Kowloon",
      "advisory_committee_description": "Ear, Nose, Throat",
      "address_1": "Rm. 708, 7th Floor, Hang Seng Castle Peak Rd. Bldg.",
      "address_2": "339 Castle Peak Rd., Cheung Sha Wan",
      "statement_or_summary": "Summary",
      "product_code": "LXB",
      "openfda": {
        "device_name": "Hearing Aid, Bone Conduction",
        "medical_specialty_description": "Ear, Nose, Throat",
        "regulation_number": "874.3302",
        "device_class": "2",
        "registration_number": [
          "3007689689",
          "3007743836",
          "3005216725",
          "3009092818",
          "3010097171",
          "9616024",
          "3012593436",
          "3009307953",
          "3006405073",
          "3005150478",
          "3018094310",
          "9710014",
          "3014990990",
          "3003477135",
          "3043654373",
          "3034209804",
          "3020283264",
          "3027588012",
          "1045254",
          "3014579188",
          "3010376846",
          "3005900820",
          "8031010",
          "9612468",
          "3007275459",
          "3003847101",
          "3007367732",
          "3033905868",
          "3009632672",
          "3005820796",
          "3013177549",
          "9613646"
        ],
        "fei_number": [
          "3003045432",
          "3007689689",
          "3007743836",
          "3005216725",
          "3009092818",
          "3010097171",
          "3012593436",
          "1000185904",
          "3009307953",
          "3006405073",
          "3005150478",
          "3018094310",
          "3002806429",
          "3000249315",
          "3014990990",
          "3003222064",
          "3003477135",
          "3043654373",
          "3034209804",
          "3020283264",
          "3027588012",
          "1045254",
          "3014579188",
          "3010376846",
          "3005900820",
          "3007275459",
          "3003847101",
          "3007367732",
          "3033905868",
          "3009632672",
          "3005820796",
          "3013177549"
        ]
      },
      "zip_code": "",
      "applicant": "Shokz Health Global Limited",
      "decision_date": "2026-08-19",
      "decision_code": "SESE",
      "country_code": "HK",
      "device_name": "Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SHOKZHEAR BM420 and SHOKZHEAR BM420MN)",
      "advisory_committee": "EN",
      "contact": "Guihong  Dai",
      "expedited_review_flag": "",
      "k_number": "K253431",
      "state": "",
      "date_received": "2025-10-01",
      "review_advisory_committee": "EN",
      "postal_code": "",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}