Happy National Speech-Language-Hearing Month! | Explore Support & Services for SLPs

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Pediatric speech-language pathologist sitting beside a young child at a low table, both looking at a QuickTalker Freestyle speech device standing upright on its kickstand with the back of the case facing the camera

WHAT THE QUICKTALKER FREESTYLE IS

Built and recognized as a speech-generating device.

For an SLP, the regulatory story is straightforward: categorized the way insurers expect, configured strictly for communication, and FDA-listed, the three things that make the funding case clean.

Speech-Generating Device (SGD)

The QuickTalker Freestyle® speech device is a dedicated SGD, making it appropriate for review under many insurers’ and Medicaid programs’ SGD coverage criteria when you seek funding for your client or student.

It has been independently reviewed by the PDAC, the CMS pricing and coding contractor, and assigned HCPCS code E2510.

FDA-Listed Medical Device

The device is listed with the U.S. Food and Drug Administration (FDA) as a medical device. As an SGD, it’s regulated under FDA’s medical-device framework and doesn’t require individual premarket approval, which helps support its use in insurance and Medicaid funding requests for your client or student.

Dedicated by design: iOS-based and configured to be used primarily for generating speech. AbleNet provides a letter confirming dedicated-device status.

CERTIFICATIONS & ACCREDITATIONS

Independently verified, continuously maintained.

Reviewed by independent auditors and regulators, not declared by us.

SOC 2 Type 2

Independently audited controls for security, availability, and confidentiality over time.

ISO 13485:2016

Certified medical-device quality management system, audited by Perry Johnson Registrars.

HQAA Accredited

Healthcare Quality Association on Accreditation, quality standards for our funding service.

FDA Listed

QuickTalker Freestyle assistive technology is listed with the U.S. Food and Drug Administration.