LRA — Hearing Aid, Tactile Class U

FDA Device Classification

FDA product code LRA covers "Hearing Aid, Tactile", a Class U medical device. Submissions are reviewed by the Unknown panel. At least 8 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
LRA
Device Class
Class U
Regulation Number
Submission Type
Review Panel
EN
Medical Specialty
Unknown
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K883853sevrain-techETANovember 17, 1988
K862471institute of logopedicsWEARABLE TWENTY-FOUR CHANNEL VIBROTACTILE VOCODERSeptember 12, 1986
K851441medeconTACTICON 1600June 27, 1985
K851655monargue intlTEACHER TMJune 20, 1985
K843433spectro industriesKANIEVSKI SENSORY AID OR DEVICENovember 14, 1984
K831501ear three systemsTACTIL EARAugust 26, 1983
K830418audiological engineeringTACTAIDMarch 10, 1983
K813057sonic systemsVIBRO-COM COMMUNICATOR #8827December 2, 1981