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Carba Linguarduc

FDA 510(k)

Class II (US FDA 510(k))

510(k) K771825

by C. R. Bard, Inc.

Identifiers

510(k) Number
K771825 FDA 510(k)
FDA Product Code
ILQ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 890.3710 FDA 510(k)
Regulation Number
890.3710 FDA 510(k)
Advisory Committee
Physical Medicine FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Carba Linguarduc is a System, Communication, Powered device classified under Physical Medicine, designed to facilitate communication and assist in the management of speech or language disorders. It operates as a powered communication aid, enabling users to interact through electronic signals or synthesized speech outputs.

This device is supplied as a reusable, non-sterile medical instrument, intended for use in clinical settings such as physical medicine rehabilitation centers. It is regulated under FDA 510(k) clearance (K771825) with a classification of Class 2 and falls under product code ILQ, adhering to regulation 890.3710. No MRI safety or sterility requirements are specified in the data.

Frequently asked questions

What clinical setting is the Carba Linguarduc designed for and how is it intended to be used?

The Carba Linguarduc is designed for use in clinical settings like physical medicine rehabilitation centers. It functions as a powered communication aid to assist users with speech or language disorders by enabling interaction through electronic signals or synthesized speech outputs. This device is not intended for home use or any other setting beyond clinical rehabilitation environments.

Is the Carba Linguarduc reusable or single-use, and what are its sterility requirements?

The Carba Linguarduc is supplied as a reusable, non-sterile medical instrument. Since it is not intended for sterile procedures, no sterility requirements are specified, and it is meant for use in clinical settings where standard infection control practices apply.

What regulatory pathway was followed for FDA clearance of the Carba Linguarduc, and what classification does it hold?

The Carba Linguarduc received FDA clearance through a 510(k) submission (K771825) under the traditional review pathway. It is classified as a Class 2 device, regulated under product code ILQ and regulation number 890.3710, with a decision of ‘Substantially Equivalent’ to a predicate device.

Are there multiple models or sizes available for the Carba Linguarduc, and how would I identify them?

Yes, the Carba Linguarduc comes in multiple models, each identified by a unique registration number (e.g., 3006789226, 3013281419, etc.). These registration numbers are listed in the FDA’s OpenFDA database and correspond to different variants of the device, though specific size or feature differences are not detailed in the provided data.

Does the Carba Linguarduc have any special handling or storage requirements beyond standard clinical practices?

The Carba Linguarduc does not specify any unique storage requirements beyond standard clinical practices for reusable medical devices. Since it is non-sterile and reusable, it should be cleaned and maintained according to manufacturer guidelines to ensure proper functionality and hygiene in its designated clinical setting.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: CARBA LINGUARDUC (K771825) — FDA 510(k) | Innolitics, K771825 FDA 510 (k) - CARBA LINGUARDUC | C.R. Bard, Inc., CARBA LINGUARDUC 510 (k) K771825 - FDA.report, PDF K771825 - Carba Linguarduc

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
C. R. Bard, Inc.
FDA Applicant
C.R. Bard, Inc.

Sources (1)

  • FDA 510(k) K771825 24 fields · synced Sep 19, 2026