{
  "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": "2026-07-20",
    "results": {
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  "results": [
    {
      "third_party_flag": "N",
      "city": "Minneapolis",
      "advisory_committee_description": "Cardiovascular",
      "address_1": "1331 Tyler St. NE, Suite 200",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "PPS",
      "openfda": {
        "device_name": "Sleeve, Head And Neck, Compressible",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.5800",
        "device_class": "2",
        "registration_number": [
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          "3014344059"
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      "zip_code": "55413",
      "applicant": "Tactile Systems Technology, Inc. (Dba Tactile Medical)",
      "decision_date": "2016-09-14",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "Flexitouch System",
      "advisory_committee": "CV",
      "contact": "Thomas A Dold",
      "expedited_review_flag": "",
      "k_number": "K153311",
      "state": "MN",
      "date_received": "2015-11-17",
      "review_advisory_committee": "CV",
      "postal_code": "55413",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
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}