K Number
K962961Device Name
SUSTAINED PHONATIONManufacturer
Date Cleared
1996-09-09
(41 days)
Product Code
Regulation Number
874.5840Type
TraditionalPanel
ENReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
§ 874.5840 Antistammering device.
(a)
Identification. An antistammering device is a device that electronically generates a noise when activated or when it senses the user's speech and that is intended to prevent the user from hearing the sounds of his or her own voice. The device is used to minimize a user's involuntary hesitative or repetitive speech.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9.