DEVICE: SPEAX Patch (B792FGN002)

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Device Record History
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Device Identifier (DI) Information
SPEAX Patch
FGN-002
Not in Commercial Distribution
FGN002
ATAIA INC.
B792FGN002
HIBCC
December 31, 2025
1
117116534 *Terms of Use
Patch for use with the SPEAX Communication System
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Device Characteristics
MR Unsafe
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
30076 Voice amplification system
An assembly of battery-powered, personal-worn, devices designed to amplify the loudness of the voice of a person with reduced vocal capacity (e.g., due to impairment of throat or chest muscles, partial paralysis of vocal cords, diminished lung capacity). It typically includes a dedicated microphone, an electronic amplifier, and a loudspeaker. Assemblies with special adaptors that are intended for use with an artificial larynx, a transoesophageal puncture tube, and/or other prostheses or implants are available. Some amplifiers are available as an integral part of an artificial larynx.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
ILQ System, Communication, Powered
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between -10 and 50 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
373849ec-060f-466d-b4c9-858e9ea0b11f
December 30, 2025
3
March 09, 2020
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
B792FGN003 10 B792FGN002 2025-12-31 Not in Commercial Distribution white cardboard box
B792FGN012 2 B792FGN003 2025-12-31 Not in Commercial Distribution cardboard box
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
8557115057
contact@ataiamedical.com
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