OSSEOUS-SnorOFF

Primary DI
08904461055031
Brand
OSSEOUS-SnorOFF
Company
EON MEDITECH PRIVATE LIMITED
Model
E31701
Device description
SnorOFF is a non-invasive neuromuscular electrical stimulation (NMES) medical device intended fordaytime use to stimulate and strengthen the muscles of the tongue in adult users.The device is designed to deliver controlled, low-level electrical stimulation to the tongue muscles duringsupervised or self-administered therapy sessions while the user is awake and conscious.By improving tongue muscle tone and responsiveness through repeated stimulation sessions, SnorOFF isintended to support upper airway stability during sleep, which may help reduce snoring and improvebreathing patterns in indicated users.SnorOFF is not intended to be used during sleep and does not provide real-time airway support.
Published
2026-03-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Product Codes#

Code, Name table
CodeName
BYPMouthpiece, Breathing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYPMouthpiece, BreathingAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08904461055024PackageGS11In Commercial Distribution
08904461055031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08904461055024089044610550248904461055024
08904461055031089044610550318904461055031

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature25 Degrees Celsius0 Degrees Celsius

Regulatory Flags#

DUNS number
930270428
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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