eXciteOSA

Primary DI
05060627480024
Brand
eXciteOSA
Company
SIGNIFIER MEDICAL TECHNOLOGIES LIMITED
Model
802300000
Device description
eXciteOSA control unit.eXciteOSA is intended for the reduction of primary snoring and obstructive sleep apnoea by strengthening tongue muscles via electrical muscle stimulation.
Published
2024-08-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
QNONeuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QNONeuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep ApneaDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060627480024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060627480024050606274800245060627480024

GMDN Terms#

Term, Definition table
TermDefinition
Sleep-disordered breathing tongue electrical stimulatorAn electronic device intended to alleviate sleep-disordered breathing conditions (e.g., snoring, obstructive sleep apnoea), by improving tongue muscular tone achieved by applying a program of electrical stimulation to the tongue during waking hours. It consists of an electrode with various contact points designed to fit around the tongue, and a remote control unit which may be software on a mobile device. It is normally available [non-prescription] over-the-counter (OTC) as a single-patient, reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
220701035
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060627480031eXciteOSA8100000002025-11-04
05060627480017eXciteOSA8016000012024-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060627480031eXciteOSASIGNIFIER MEDICAL TECHNOLOGIES LIMITEDQNO2025-11-04
05060627480017eXciteOSASIGNIFIER MEDICAL TECHNOLOGIES LIMITEDQNO2024-08-14