{
  "format": "devicerts.device.v1",
  "cite_as": "Heating Tens, FT-615, Hivox Biotek Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/heating-tens-ft-615-nuh (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/heating-tens-ft-615-nuh",
    "json_url": "https://devicerts.com/devices/heating-tens-ft-615-nuh.json",
    "markdown_url": "https://devicerts.com/devices/heating-tens-ft-615-nuh.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      }
    ],
    "registry_records_last_synced": "2026-10-22",
    "status_as_of": "2026-11-15",
    "license": "CC BY 4.0",
    "license_url": "https://creativecommons.org/licenses/by/4.0/",
    "license_scope": "The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.",
    "attribution": "DevicErts, https://devicerts.com/devices/heating-tens-ft-615-nuh",
    "disclaimer": "Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails."
  },
  "device": {
    "name": "Heating Tens, FT-615",
    "registry_name": "Heating Tens, FT-615",
    "url": "https://devicerts.com/devices/heating-tens-ft-615-nuh",
    "manufacturer": {
      "name": "Hivox Biotek Inc.",
      "url": "https://devicerts.com/manufacturers/hivox-biotek-inc",
      "country": "Taiwan",
      "country_basis": null,
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "United States"
    },
    "classification": [
      {
        "class": "Class II",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K232675",
            "registries": [
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            ]
          }
        ]
      }
    ],
    "product_codes": [
      "NUH"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The Heating Tens, FT-615 is a Transcutaneous Nerve Stimulator. It is classified as a Stimulator, Nerve, Transcutaneous, Over-the-counter device. The device is used for stimulation.\n\nThe Heating Tens, FT-615 is supplied by Hivox Biotek, Inc. and is classified under product code NUH. It received FDA 510(k) clearance under approval number K232675. The device was reviewed by the Neurology advisory committee.",
      "ai_generated": true,
      "generated_on": "2026-09-28",
      "note": "Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record."
    },
    "noindex": false
  },
  "authorizations": [
    {
      "registry": "510(k)",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K232675",
      "number_label": null,
      "device_udi_di": null,
      "date": "2023-10-05",
      "date_kind": "decision",
      "decision_code": "SESE",
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
  "recalls": [],
  "eu_market_availability": null,
  "properties": [
    {
      "group": "Identifiers",
      "fields": [
        {
          "label": "510(k) Number",
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            {
              "value": "K232675",
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              ]
            }
          ]
        },
        {
          "label": "FDA product code",
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            {
              "value": "NUH",
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            {
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            }
          ]
        },
        {
          "label": "Regulation",
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            {
              "value": "21 CFR Part 882.5890",
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            }
          ]
        },
        {
          "label": "Advisory committee",
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            {
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        }
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    }
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}