Identity
- Trade Name
- Romet FDA UDI
- Generic Name
- Voice amplification system FDA UDI
- Device Name
- After undergoing surgery for partial or total laryngectomy due to throat cancer or accidental damage to the larynx, with the consequent removal of the vocal cords, one is no longer able to speak. This condition is due to the absence of vibrations which were previously produced by the vocal cords. To overcome this challenge, there is no solution other than to artificially produce these vibrations. The ROMET Electronic Larynx or Electrolarynx, produces such vibrations and permits the user to emit clear and very comprehensible vocal sounds. The Romet Model R310 Electrolarynx Includes: 2 Year Warranty Delrin Barrel with Exclusive, New Soft-Grip Barrel w/Anti-Roll Feature Larger, Ergonomic On/Off Button External Pitch and Volume Controls Two-9V Lithium Batteries w/Smart Charger Lanyard (Important reminder - See a Speech Language Pathologist for help learning where to best use the device on your neck) FDA UDI
- Model / Reference
- R310 FDA UDI
- Description
- After undergoing surgery for partial or total laryngectomy due to throat cancer or accidental damage to the larynx, with the consequent removal of the vocal cords, one is no longer able to speak. This condition is due to the absence of vibrations which were previously produced by the vocal cords. To overcome this challenge, there is no solution other than to artificially produce these vibrations. The ROMET Electronic Larynx or Electrolarynx, produces such vibrations and permits the user to emit clear and very comprehensible vocal sounds. The Romet Model R310 Electrolarynx Includes: 2 Year Warranty Delrin Barrel with Exclusive, New Soft-Grip Barrel w/Anti-Roll Feature Larger, Ergonomic On/Off Button External Pitch and Volume Controls Two-9V Lithium Batteries w/Smart Charger Lanyard (Important reminder - See a Speech Language Pathologist for help learning where to best use the device on your neck) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860009460522 FDA UDI
- FDA Product Code
- ESE FDA UDI
- GMDN Term
- Voice amplification system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.3375 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Voice amplification system
Romet by Fountain Head Marketing Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Fountain Head Marketing Inc
Sources (1)
- FDA UDI 17d55135-3bde-4d8b-909f-60322fe0014a 34 fields · synced Jun 1, 2026