FDA 510(k) Applications for Medical Device Product Code "LXV"
(Apparatus, Vestibular Analysis)

FDA 510(k) Number Applicant Device Name Decision Date
K121590 CAPACITY SPORTS, LLC VESTIBULAR ANALYSIS APPARATUS 09/20/2012
K081602 CLEARWATER CLINICAL LIMITED DIZZYFIX 09/19/2008
K190735 Highmark Innovations Inc. DBA Highmark Interactive EQ Balance 08/16/2019
K102364 INTERACOUSTICS A/S NYDIAG 200 12/23/2010
K200529 Interacoustics A/S Orion 08/12/2020
K192652 Interacoustics A/S TRV 05/27/2020
K173669 King-Devick Technologies, Inc. K-D Balance 04/02/2018
K070085 MEDICAA (URUGUAY) S.A. BALANCE REHABILITATION UNIT (BRU) 02/26/2007
K183661 Quadrant Biosciences ClearEdge Balance System 10/22/2019
K070676 SPORTKAT, LLC KOREBALANCE (KINESTHETIC ABILITY TRAINER) 04/18/2007
K971549 TARGET HEALTH, INC. VMT SYSTEM 10/05/1998
K220231 UltraThera Technologies, Inc. GyroStim 04/27/2022
K082634 VERTIGONE, INC. VERTIGONE BPPV GOGGLE 04/07/2009
K071973 VESTICON EPLEY OMNIAX 06/20/2008


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