{
  "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": "2026-08-03",
    "results": {
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  "results": [
    {
      "third_party_flag": "N",
      "city": "North Kansas City",
      "advisory_committee_description": "Physical Medicine",
      "address_1": "1419 Murray St.",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "OSD",
      "openfda": {
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        "device_name": "Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature",
        "medical_specialty_description": "Physical Medicine",
        "regulation_number": "890.5670",
        "device_class": "2"
      },
      "zip_code": "64116",
      "applicant": "Plus EV Holdings, Inc. D/B/A Intimate Rose",
      "decision_date": "2026-07-27",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "Intimate Rose Pelvic Wand (Purple); Intimate Rose Bendable Pelvic Wand (Orange); Intimate Rose Temperature Pelvic Wand (Yellow)",
      "advisory_committee": "PM",
      "contact": "Aaron  Wilt",
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      "k_number": "K250419",
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      "review_advisory_committee": "OB",
      "postal_code": "64116",
      "decision_description": "Substantially Equivalent",
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