OSSEOUS-SnorOFF

GUDID 08904461055024

SnorOFF is a non-invasive neuromuscular electrical stimulation (NMES) medical device intended for daytime 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 during supervised or self-administered therapy sessions while the user is awake and conscious. By improving tongue muscle tone and responsiveness through repeated stimulation sessions, SnorOFF is intended to support upper airway stability during sleep, which may help reduce snoring and improve breathing patterns in indicated users. SnorOFF is not intended to be used during sleep and does not provide real-time airway support.

EON MEDITECH PRIVATE LIMITED

Sleep-disordered breathing tongue electrical stimulator

• Primary Device ID: 08904461055024
• NIH Device Record Key: d4d4fc6d-d273-4255-b6cc-01a15acddf3a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSSEOUS-SnorOFF
• Version Model Number: E31701
• Company DUNS: 930270428
• Company Name: EON MEDITECH PRIVATE LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 25 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 25 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 25 Degrees Celsius and 0 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08904461055024 [Package]; Contains: 08904461055031; Package: Laminated Box [1 Units]; In Commercial Distribution
GS1	08904461055031 [Primary]

FDA Product Code

• BYP: Mouthpiece, Breathing

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-23
• Device Publish Date: 2026-03-13

Devices Manufactured by EON MEDITECH PRIVATE LIMITED

• 00890446104932 - OSSEOUS-Endoscrub 4 mm ( 0° ): 2026-03-23 The Endo scrub is a single-use, sterile, accessory device designed for use with rigid endoscopes. It is a surgical tool, a devic
• 08904428745326 - OSSEOUS- Skin Closure Tape: 2026-03-23
• 08904428745333 - OSSEOUS- Skin Preparation Pad: 2026-03-23 The Skin preparation pad are single use tracheostomy pads that provide protection between the tracheal cannula and the skin and
• 08904428798421 - OSSEOUS- ShowerProtect: 2026-03-23 Shower guard is used to temporarily replace the HME during showering.
• 08904428798438 - OSSEOUS- NeckFit Tube Holder: 2026-03-23 Made with soft foam and comfort fabric. Can be easily attached to the rib of laryngectomy tube or button. Dual-piece special des
• 08904428798483 - OSSEOUS- Tube Cleaning Brush - 8mm: 2026-03-23 The tube cleaning brush is used to clean Laryngectomy tube &Laryngectomy button
• 08904428798469 - OSSEOUS-Cleaning Pad: 2026-03-23
• 08904428799749 - OSSEOUS- Adhesion Remover Pad: 2026-03-23 The Adhesive removal pad are single use tracheostomy pads that provide protection between the tracheal cannula and the skin and