iTalk4 10000028

GUDID 00186648000531

The easiest way to provide an individual with four side-by-side communication choices is with the iTalk4 speech device. Activate the colored top to play the desired message. New messages are easily and quickly recorded to the iTalk4 on the fly, or use the levels pre-record up to three sets of messages ahead of time. Includes ableCARE on-demand support Built ableSTRONG to endure drops and other environmental conditions Made from ableSAFE materials and tested by third-party safety labs Common Uses Provide a unique response to a question like "What is the weather like outside?" Respond to an assessment Provide a way to make unique requests like "I need help", "I'm done", "I need to use the bathroom", and "I'm thirsty" Add communication to a switch controlled toy or appliance Features Better than ever digital sound output suitable for almost any environment Clear snap cover to attach picture symbols and provide communication context to the user Symbol Overlays Symbol overlays are not included with the iTalk4. Download the free AbleNet Symbol Overlay app for iPad to create symbol overlays for your AbleNet speech device.

Ablenet, Inc.

Assistive speech generator

• Primary Device ID: 00186648000531
• NIH Device Record Key: 6e2e435b-8fce-4a72-8ca4-881f65a3ea6c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iTalk4
• Version Model Number: 10000028
• Catalog Number: 10000028
• Company DUNS: 791664543
• Company Name: Ablenet, 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00186648000531 [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: 2023-06-29
• Device Publish Date: 2023-06-21

Devices Manufactured by Ablenet, Inc.

• 00186648000609 - Blue2 4th Generation: 2023-07-03
• 00850011150276 - Blue2 FT: 2023-07-03
• 00850011150283 - QuickTalker Freestyle: 2023-07-03 The QuickTalker Freestyle is a robust and flexible speech device that allows your client or student with a speech impairment to
• 00850011150290 - QuickTalker Freestyle Mini: 2023-07-03 The QuickTalker Freestyle is a robust and flexible speech device that allows your client or student with a speech impairment to
• 00186648000180 - Pillow Switch: 2023-06-30
• 00186648000203 - Jelly Bean: 2023-06-30
• 00186648000210 - Specs Switch - Red: 2023-06-30
• 00186648000227 - Big Red Switch: 2023-06-30