Identity
- Trade Name
- MICROSOFT FDA UDI
- Generic Name
- Assistive speech generator FDA UDI
- Model / Reference
- XHU-00001 FDA UDI
Identifiers
- Primary DI / UDI-DI
- G549XHU000010 FDA UDI
- FDA Product Code
- ILQ FDA UDI
- GMDN Term
- Assistive speech generator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.3710 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Assistive speech generator
Microsoft by RCS Management Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Assistive speech generator.
- QuickTalker Freestyle — AbleNet Inc. · Class II
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- UbiDuo — S-Comm, Inc. · Class II
- UbiDuo — S-Comm, Inc. · Class II
- UbiDuo — S-Comm, Inc. · Class II
- QuickTalker Freestyle Mini — AbleNet Inc. · Class II
- UbiDuo — S-Comm, Inc. · Class II
- QuickTalker Freestyle Mini — AbleNet Inc. · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- RCS Management Corporation
Sources (1)
- FDA UDI a69afdf6-2cbc-40e6-9575-71d70c7b9637 32 fields · synced May 30, 2026