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iTalk4

Ablenet, Inc. · Model 10000028 · UDI-DI 00186648000531

ILQ
10
510(k) clearances
743
Adverse events (22 deaths)
19
Recalls
47
Facilities

Description

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.

Recalls

DateFirmReason
2026-07-08Tobii Dynavox LlcUnder certain conditions, the battery mounting tabs may become damaged, allowing the battery to move within the device enclosure, potentially leading to an internal short circuit.
2026-07-08Tobii Dynavox LlcUnder certain conditions, the battery mounting tabs may become damaged, allowing the battery to move within the device enclosure, potentially leading to an internal short circuit.
2023-02-24Tobii Dynavox LlcProblem maintaining the stable placement of the battery may come loose from the housing and become damaged.
2022-05-31Baxter Healthcare CorporationAn issue has been identified with Phillips (Emergin) and Longleaf non relay (Connexall, Vocera, Cerner) wireless integrations used with NaviCare/Voalte Nurse Call, software version
2022-04-13Baxter Healthcare CorporationFirm discovered a firmware memory leak with a supplier-manufactured component.
2022-04-13Baxter Healthcare CorporationFirm discovered a firmware memory leak with a supplier-manufactured component.
2022-03-28Medminder Systems, Inc.Discontinuation of the Emergency Alert watch or pendant will no longer connect to the emergency alert system for all models. Older Model (legacy) without screen medical alert feat
2021-10-14Hill-Rom Inc.An unrecoverable error may occur where a component will fail to complete the reboot cycle, become non-functional and must be replaced.
2021-10-11Forbes Rehab Services IncWarning Added: Using damaged cables or chargers, or charging when moisture is present, can cause fire, electric shock, injury, or damage to Speech Generating Device or other proper
2017-12-14Dynavox Systems LlcThe battery is integral to the device. If the device sits unused and is not charged for a lengthy period of time (a few months) the battery will go into a deep discharge state and

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.