Genio System 2.1 - The Genio External Stimulator Sales Kit includes one External Stimulator (Primary DI: 05404031018693) and a Surgeon Manual (instructions for use).
2025-08-26
Nyxoah
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3017191859 | 3017191859 | NYXOAH SA | 1 | N | 2026-01-01 | Rue Edouard Belin 12 Mont-Saint-Guibert Brabant Wallon BE 1435 |
| 3030384402 | 3030384402 | NYXOAH INC | 1 | Y | 2026-01-01 | 350 Springfield Ave Ste 200 Summit NJ US 07901 |
| 3030384719 | 3030384719 | Nyxoah SA Milmort | 1 | N | 2026-01-01 | Val du Geer Facility Rue Haute Claire1 Herstal Liege BE 4041 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 342359 | 2054597096 | P240024 | Genio® System 2.1 | MNQ | 2025-08-08 |
| 342368 | 2054597096 | P240024 | Genio® System 2.1 | MNQ | 2025-08-08 |
| 342401 | 2054597096 | P240024 | Genio® System 2.1 | MNQ | 2025-08-08 |
GUDID#
Genio System 2.1 - The Disposable Patch is a single-use adhesive patch placed on the skin under the chin each night by the user. The Activation Chip is snapped onto the Disposable Patch using a button connector. Once snapped together, stimulation energy can be transmitted wirelessly to the Implantable Stimulator. The Disposable Patch is comprised of a flexible Printed Circuit Board (PCB) (the antenna) and an adhesive patch.
2025-08-27
Genio System 2.1 - The Implantable Stimulator Model #2954 is a single-use, sterile, small saddle-shaped implant that delivers stimulation to both hypoglossal nerve branches (i.e. left and right). The body of the Implantable Stimulator consists of an energy receiving antenna and an electrical circuit both encapsulated in a ceramic housing, and two lateral legs with a pair of paddle electrodes. It is powered and controlled by either the Activation Chip or External Stimulator externally. The Implantable Stimulator does not include a battery or a microcontroller or software. Packaged with the Implantable Stimulator Model #2954 is the Surgical Template. The Surgical Template is a single use, sterile accessory which can be optionally used for preparation of the implantation site.
2025-08-26
Genio System 2.1 - The Genio Implantable Stimulator Model #2954 Sales Kit contains one Implantable Stimulator Model #2954 and Surgical Template (Primary DI: NX-PKG-002954) and a Surgeon Manual (instructions for use).
2025-08-26
Genio System 2.1 - The Genio Sleep Lab Application software is used to configure the Activation Chip stimulation parameters. This remote application runs on a small mini-computer (Repeater, provided as part of the Genio Sleep Lab Kit - Primary DI: 05404031025301) and uses Bluetooth low energy (BLE) protocol to enable the operator to configure/customize the Activation Chip stimulation parameters. Once the Activation Chip is connected to a Disposable Patch, the Sleep Lab Application can be used to perform Activation Chip check-ups, read usage data stored in the AC and program/adjust the stimulation parameters.
2025-08-26
Genio System 2.1 - The Activation Chip can be controlled by an optional Genio Smartphone Application software, designed to operate on both Android and iOS devices. The Smartphone Application software allows the patient to pause and resume stimulation and to increase/decrease the treatment amplitude within a pre-configured range. The Smartphone Application software uses Bluetooth low energy (BLE) protocol to communicate with a paired Activation Chip.
2025-08-26
Genio System 2.1 - The External Stimulator is a single-use, sterile accessory that allows the surgeon to activate the Implantable Stimulator and verify the functionality of the implant during the surgical procedure. The External Stimulator contains a power button with an LED indicator, a pre-charged battery and a retractable scaling mechanism to control the stimulation intensity delivered to the implant.
2025-08-26
Genio System 2.1 - The Genio Patient Kit contains one Activation Chip Model #2364 (Primary DI: 05404031024847) one Charging Unit Model #2238 with power adapters (Primary DI: 05404031024823), three boxes of Disposable Patches (Primary DI: 05404031018723), a Patient Manual (instructions for use) and a Quick Setup Guide. The Patient Kit is provided to the patient at the time of initial device activation.
2025-08-26
Genio System 2.1 - The Charging Unit and its power adapter are used to recharge the Activation Chip battery during the day in order to be ready for use the following night. The Charging Unit is comprised of a docking area to plug the Activation Chip in, a power LED indicator and a micro-USB port to connect to the power adapter.
2025-08-26
Genio System 2.1 - The Activation Chip is the power source for the Implantable Stimulator. The Activation Chip contains a rechargeable battery, electronics for Bluetooth communication and electromagnetic power transmission, and a microprocessor that stores the user-specific stimulation parameters. The Activation Chip must be connected to the Disposable Patch and placed on the chin each night for stimulation to be delivered, and the battery must be recharged daily.
2025-08-26
Genio System 2.1 - The Genio Sleep Lab Kit is comprised of the Repeater containing the Genio Sleep Lab Application, a power supply with adaptors, ethernet cables and instructions for use.
2025-08-26