L8

GUDID B925TP08EL80

L8 Speech Generating Device

Smartbox Assistive Technology Inc.

Voice synthesizer/digitizer Voice synthesizer/digitizer Voice synthesizer/digitizer Voice synthesizer/digitizer Voice synthesizer/digitizer Voice synthesizer/digitizer Voice synthesizer/digitizer Voice synthesizer/digitizer Voice synthesizer/digitizer Voice synthesizer/digitizer Voice synthesizer/digitizer Voice synthesizer/digitizer Voice synthesizer/digitizer Voice synthesizer/digitizer Voice synthesizer/digitizer Voice synthesizer/digitizer Voice synthesizer/digitizer

• Primary Device ID: B925TP08EL80
• NIH Device Record Key: 45bc786f-8a16-4b60-bd6e-9e7b3338336e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: L8
• Version Model Number: TP08E-L8
• Company DUNS: 047962036
• Company Name: Smartbox Assistive Technology Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B925TP08EL80 [Primary]

FDA Product Code

• ILQ: System, Communication, Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-04
• Device Publish Date: 2023-09-26

Devices Manufactured by Smartbox Assistive Technology Inc.

• 00860011903901 - G13: 2024-03-28 G13 Speech Generating device
• B925TP08EL80 - L8: 2023-10-04L8 Speech Generating Device
• B925TP08EL80 - L8: 2023-10-04 L8 Speech Generating Device
• B925TP10EL100 - L10.2: 2023-10-04 L10.2 Speech Generating Device
• B925TP10HL100 - L10: 2023-10-04 L10.9 Speech Generating Device
• B925TS08EL80 - L8 Slimline: 2023-10-04 L8 Slimline Speech Generating Device
• B925TS10EL100 - L10.2 Slimline: 2023-10-04 L10.2 Slimline Speech Generating Device
• B925TS10HL100 - L10 Slimline: 2023-10-04 L10.9 Slimline Speech Generating Device