DEVICE: SPEAX Patch for Home Use (B792FGN010)

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Device Record History
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Device Identifier (DI) Information
SPEAX Patch for Home Use
FGN-010
In Commercial Distribution
FGN010
ATAIA INC.
B792FGN010
HIBCC

1
117116534 *Terms of Use
Patch for use with the SPEAX Digital Communication System for Home Use
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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
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
f4f86017-1d4c-453a-b749-0a276743bcb9
January 13, 2023
4
January 26, 2022
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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
B792FGN014 5 B792FGN010 In Commercial Distribution white cardboard box
B792FGN015 10 B792FGN010 In Commercial Distribution white cardboard box
B792FGN016 1 B792FGN010 In Commercial Distribution white 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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