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Genio System 2.1

by Nyxoah S.A.

PMA P240024

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

PMA P240024↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP240024 Date8 Aug 2025ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Generic Name
Stimulator, hypoglossal nerve, implanted, apnea
PMA Number
FDA Product Code
MNQ
Device Class
Class III
Advisory Committee
Anesthesiology
FDA Decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Genio System 2.1 is an implanted hypoglossal nerve stimulator designed for the treatment of moderate to severe obstructive sleep apnea (OSA). It delivers targeted electrical stimulation to the hypoglossal nerve, promoting airway patency during sleep. This device is classified as a Class III medical device under FDA regulations and is intended for adult patients aged 22 and older who have failed, cannot tolerate, or are ineligible for standard OSA treatments such as PAP therapy, oral appliances, or pharmacotherapy.

The system includes an Implantable Stimulator (Model #2954), Surgical Template, External Stimulator, Disposable Patch, Activation Chip (Model #2364), Charging Unit (Model #2238), Sleep Lab Application, Repeater, and Smartphone Application. It is supplied as a reusable, implantable device with disposable consumables, requiring surgical implantation and subsequent activation. The system is approved under FDA PMA (P240024) and is intended for use in clinical settings by trained healthcare professionals. Sterility and proper handling are critical for the implantable components, while the external components are designed for repeated use with disposable accessories.

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Genio System 2.1 used for?

    The Genio System 2.1 is an implanted hypoglossal nerve stimulator designed for treating moderate to severe obstructive sleep apnea (OSA) in adults aged 22 and older who have failed, cannot tolerate, or are ineligible for standard treatments like PAP therapy, oral appliances, or pharmacotherapy.

  • What components are included in the Genio System 2.1?

    The system includes an Implantable Stimulator (Model #2954), Surgical Template, External Stimulator, Disposable Patch, Activation Chip (Model #2364), Charging Unit (Model #2238), Sleep Lab Application, Repeater, and Smartphone Application.

  • Is the Genio System 2.1 reusable or single-use?

    The system includes reusable implantable components and disposable consumables. The implantable stimulator is designed for long-term use, while accessories like the patch are single-use.

  • What are the storage requirements for the Genio System 2.1?

    The device requires proper handling and storage to maintain sterility for implantable components. External components should be stored in a clean, dry environment when not in use.

  • What is the regulatory status of the Genio System 2.1?

    The Genio System 2.1 is approved under FDA PMA (P240024) and is classified as a Class III medical device for the treatment of moderate to severe obstructive sleep apnea.