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Provox Nid Voice Rehabilitation System, Model Ref 7101 to 7134

FDA 510(k)

Class II (US FDA 510(k))

510(k) K043138

by Atos Medical AB

Identifiers

510(k) Number
K043138 FDA 510(k)
FDA Product Code
EWL FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 874.3730 FDA 510(k)
Regulation Number
874.3730 FDA 510(k)
Advisory Committee
Ear, Nose, Throat FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Provox Nid Voice Rehabilitation System, Model Ref 7101 to 7134 is a prosthesis, laryngeal (Taub) device intended for voice rehabilitation following laryngectomy. It is classified as a Class II medical device under FDA regulation number 874.3730 and product code EWL.

This device received FDA 510(k) clearance (K043138) on November 22, 2004, as substantially equivalent to a predicate device. It is manufactured by Atos Medical AB and supplied as a patient-changeable voice prosthesis with a wide safety medallion to prevent airway intrusion, available in sizes ranging from Model Ref 7101 to 7134.

Frequently asked questions

What is the Provox Nid Voice Rehabilitation System used for?

The Provox Nid Voice Rehabilitation System is a laryngeal prosthesis intended for voice rehabilitation following laryngectomy, helping patients regain speech after surgical removal of the larynx.

How is the Provox Nid Voice Rehabilitation System supplied and changed?

The device is supplied as a patient-changeable voice prosthesis, meaning patients or caregivers can replace it without clinical assistance, featuring a wide safety medallion design to prevent accidental airway intrusion during use or handling.

What sizes are available for the Provox Nid Voice Rehabilitation System?

The Provox Nid Voice Rehabilitation System is available in a range of sizes from Model Ref 7101 to 7134, allowing clinicians to select the appropriate fit based on individual patient anatomy following laryngectomy.

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: Provox NiD - Atos Medical, Provox® NiD™ 17 Fr, 6 mm - Shop Atos Medical, Provox Nid Voice Rehabilitation System, Model Ref 7101 to 7134

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Atos Medical AB

Sources (1)

  • FDA 510(k) K043138 24 fields · synced Sep 23, 2026