eXciteOSA

Primary DI
05060627480031
Brand
eXciteOSA
Company
SIGNIFIER MEDICAL TECHNOLOGIES LIMITED
Model
810000000
Device description
eXciteOSA remote control. eXciteOSA is intended for the reduction of primary snoring and obstructive sleep apnoea by strengthening tongue muscles via electrical muscle stimulation.
Published
2025-11-04
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
05060627480031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060627480031050606274800315060627480031

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.

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
05060627480017eXciteOSA8016000012024-08-14
05060627480024eXciteOSA8023000002024-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060627480017eXciteOSASIGNIFIER MEDICAL TECHNOLOGIES LIMITEDQNO2024-08-14
05060627480024eXciteOSASIGNIFIER MEDICAL TECHNOLOGIES LIMITEDQNO2024-08-14