FDA UDI
In Commercial Distribution
🇺🇸 United States
OSSEOUS-SnorOFF
DI: 08904461055031
·
Model: E31701
·
EON MEDITECH PRIVATE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- OSSEOUS-SnorOFF
- Primary DI
- 08904461055031
- Version / Model
- E31701
- Company Name
- EON MEDITECH PRIVATE LIMITED
- Labeler DUNS
- 930270428
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-13
- Public Version
- 1
- Public Version Date
- 2026-03-23
- Public Version Status
- New
- Public Device Record Key
- d4d4fc6d-d273-4255-b6cc-01a15acddf3a
Device Description
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BYP | Mouthpiece, Breathing | Anesthesiology | 868.5620 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63489 | Sleep-disordered breathing tongue electrical stimulator | An 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 08904461055024 | GS1 | Laminated Box | 1 | In Commercial Distribution | |
| Primary | 08904461055031 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 25 – Degrees Celsius