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.
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.
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.