Identity
- Trade Name
- Romet FDA UDI
- Generic Name
- Voice amplification system FDA UDI
- Device Name
- The R600 is the latest and modern electronic larynx model to hit the market. Being the most economical option out there, this artificial larynx is designed for the voice impaired adult providing countless benefits and modern improvements over other artificial larynx devices, including: Permanently installed Li-Ion battery saving you money on AA or AAA batteries. Gun metal electroplated Aluminum Barrel Installed Li-Ion battery offers a safer alternative to NiMH batteries. (NiMH depletes charge even when not in use) 30 hours of reliable speaking time. USB rechargeable. No batteries needed! USB charging cable, charging brick, and lanyard is included! Operating instructions, basic use, programming, battery information and more can be found in the Operating Instructions included with each box. Please be sure to consult with your SLP for the most optimal experience. FDA UDI
- Model / Reference
- R600 FDA UDI
- Description
- The R600 is the latest and modern electronic larynx model to hit the market. Being the most economical option out there, this artificial larynx is designed for the voice impaired adult providing countless benefits and modern improvements over other artificial larynx devices, including: Permanently installed Li-Ion battery saving you money on AA or AAA batteries. Gun metal electroplated Aluminum Barrel Installed Li-Ion battery offers a safer alternative to NiMH batteries. (NiMH depletes charge even when not in use) 30 hours of reliable speaking time. USB rechargeable. No batteries needed! USB charging cable, charging brick, and lanyard is included! Operating instructions, basic use, programming, battery information and more can be found in the Operating Instructions included with each box. Please be sure to consult with your SLP for the most optimal experience. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860009460546 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 e939b757-cdb2-4600-abe8-aff6719a0fbe 34 fields · synced Jun 8, 2026