# CapMedic

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/capmedic-caf>
- Manufacturer: [Cognita Labs, LLC](https://devicerts.com/manufacturers/fda-fei-3017200972) (FDA registration: United States)
- Device class: Class II (US FDA)
- FDA product code: CAF

## Overview

*AI-generated summary, 2026-10-06. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record.*

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.

CapMedic 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.

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K183586 · decision 2019-09-13 · decision SESE · status: Active

## Recalls

No recall on record.

## Identifiers

- 510(k) Number: K183586 [FDA 510(k)]
- FDA product code: CAF [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 868.5630 [FDA 510(k)]
- Advisory committee: Anesthesiology [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: CapMedic, Cognita Labs, LLC. deviCERTS medical device catalogue. https://devicerts.com/devices/capmedic-caf (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/capmedic-caf.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). 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
- 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.