{
  "format": "devicerts.device.v1",
  "cite_as": "Accufit, Mettler Electronics Corporation. deviCERTS medical device catalogue. https://devicerts.com/devices/accufit-ipf-k233926 (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/accufit-ipf-k233926",
    "json_url": "https://devicerts.com/devices/accufit-ipf-k233926.json",
    "markdown_url": "https://devicerts.com/devices/accufit-ipf-k233926.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/accufit-ipf-k233926",
    "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": "Accufit",
    "registry_name": "accufit",
    "url": "https://devicerts.com/devices/accufit-ipf-k233926",
    "manufacturer": {
      "name": "Mettler Electronics Corporation",
      "url": "https://devicerts.com/manufacturers/fda-fei-2013558",
      "country": null,
      "country_basis": null,
      "fda_registration_country": "United States"
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "United States"
    },
    "classification": [
      {
        "class": "Class II",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K233926",
            "registries": [
              "FDA 510(k)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "IPF"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The Accufit is a Physical Medicine Device (Product Code IPF) designed for muscle reeducation and stimulation. It delivers controlled electrical impulses to facilitate neuromuscular recovery, aiding in the rehabilitation of muscle function following injury, surgery, or neurological conditions. The device incorporates two waveforms derived from the predecessor Mettler Sys*Stim ME240, ensuring compatibility with established therapeutic protocols. Its classification as a Class 2 device reflects its role in non-invasive physical medicine applications under FDA oversight.\n\nThe Accufit is supplied as a reusable medical device intended for clinical use in physical therapy or rehabilitation settings. It requires proper sterilization and maintenance per manufacturer guidelines to ensure safety and efficacy. The device is not labeled as MRI-safe or unsafe, and its operation does not involve single-use consumables. Authorized under FDA 510(k) clearance (K233926) via the Traditional pathway, it adheres to regulatory standards for Physical Medicine devices. Storage and handling must comply with the manufacturer’s instructions to preserve functionality and performance.",
      "ai_generated": true,
      "generated_on": "2026-10-01",
      "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": "K233926",
      "number_label": null,
      "device_udi_di": null,
      "date": "2024-03-21",
      "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",
          "values": [
            {
              "value": "K233926",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA product code",
          "values": [
            {
              "value": "IPF",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Classification",
      "fields": [
        {
          "label": "Device class",
          "values": [
            {
              "value": "Class II",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Regulation",
          "values": [
            {
              "value": "21 CFR Part 890.5850",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Advisory committee",
          "values": [
            {
              "value": "Physical Medicine",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA decision",
          "values": [
            {
              "value": "SESE",
              "registries": [
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              ]
            }
          ]
        }
      ]
    }
  ]
}