| Primary Device ID | B792FGN010 |
| NIH Device Record Key | f4f86017-1d4c-453a-b749-0a276743bcb9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SPEAX Patch for Home Use |
| Version Model Number | FGN-010 |
| Catalog Number | FGN010 |
| Company DUNS | 117116534 |
| Company Name | ATAIA INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B792FGN010 [Primary] |
| HIBCC | B792FGN014 [Package] Package: white cardboard box [5 Units] In Commercial Distribution |
| HIBCC | B792FGN015 [Package] Package: white cardboard box [10 Units] In Commercial Distribution |
| HIBCC | B792FGN016 [Package] Package: white cardboard box [1 Units] In Commercial Distribution |
| ILQ | System, Communication, Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-02-03 |
| Device Publish Date | 2022-01-26 |
| B792FGN010 - SPEAX Patch for Home Use | 2022-02-03Patch for use with the SPEAX Digital Communication System for Home Use |
| B792FGN010 - SPEAX Patch for Home Use | 2022-02-03 Patch for use with the SPEAX Digital Communication System for Home Use |
| B792FGN011 - SPEAX Digital Communication System for Home Use | 2022-02-03 SPEAX Digital Communication System for Home Use including Digital Communicator and Patches for Home Use |
| B792FGN009 - SPEAX Digital Communicator Subscription Package | 2022-01-28 The Digital Communicator Subscription Package for the SPEAX Communication System, including 1 Digital Communicator and 20 Patche |
| B792FGN008 - SPEAX Digital Communicator Trial Package | 2021-10-18 The Digital Communicator Trial Package for the SPEAX Communication System, including 1 Digital Communicator and 10 Patches. |
| B792FGN007 - SPEAX Digital Communicator | 2021-07-13 Digital Communicator for use with the SPEAX Communication System |
| B792FGN001 - SPEAX Communicator | 2020-03-17 Communicator for use with the SPEAX Communication System |
| B792FGN003 - SPEAX Patch | 2020-03-17 Patch for use with the SPEAX Communication System |
| B792FGN004 - SPEAX Starter Package | 2020-03-17 The Starter Package for the SPEAX Communication System, including 5 Communicators and 30 Patches |