{
  "format": "devicerts.device.v1",
  "cite_as": "CapMedic, Cognita Labs, LLC. deviCERTS medical device catalogue. https://devicerts.com/devices/capmedic-caf (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/capmedic-caf",
    "json_url": "https://devicerts.com/devices/capmedic-caf.json",
    "markdown_url": "https://devicerts.com/devices/capmedic-caf.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/capmedic-caf",
    "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": "CapMedic",
    "registry_name": "CapMedic",
    "url": "https://devicerts.com/devices/capmedic-caf",
    "manufacturer": {
      "name": "Cognita Labs, LLC",
      "url": "https://devicerts.com/manufacturers/fda-fei-3017200972",
      "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": "K183586",
            "registries": [
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            ]
          }
        ]
      }
    ],
    "product_codes": [
      "CAF"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "CapMedic is a device designed to provide real-time audio-visual interactive guidance on correct inhaler use. It is a prescription-only device that helps users with proper inhaler technique.\n\nCapMedic is supplied by Cognita Labs, LLC and has FDA 510K clearance with product code CAF. The device is intended to simplify respiratory care by enabling regular and correct inhaler use, though it does not replace the inhaler's packaged instructions.",
      "ai_generated": true,
      "generated_on": "2026-10-06",
      "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": "K183586",
      "number_label": null,
      "device_udi_di": null,
      "date": "2019-09-13",
      "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": "K183586",
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              ]
            }
          ]
        },
        {
          "label": "FDA product code",
          "values": [
            {
              "value": "CAF",
              "registries": [
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            }
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    {
      "group": "Classification",
      "fields": [
        {
          "label": "Device class",
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            {
              "value": "Class II",
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            }
          ]
        },
        {
          "label": "Regulation",
          "values": [
            {
              "value": "21 CFR Part 868.5630",
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        },
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}