FDA Product Code LXV: Apparatus, Vestibular Analysis
Leading manufacturers include Interacoustics A/S, Capacity Sports, LLC and King-Devick Technologies, Inc..
22
Total
22
Cleared
154d
Avg days
1977
Since
Stable submission activity - 0 submissions in the last 2 years
FDA 510(k) Cleared Apparatus, Vestibular Analysis Devices (Product Code LXV)
22 devices
Cleared
Apr 27, 2022
GyroStim
Ultrathera Technologies, Inc.
Ear, Nose, Throat
90d
Cleared
Aug 12, 2020
Orion
Interacoustics A/S
Ear, Nose, Throat
163d
Cleared
May 27, 2020
TRV
Interacoustics A/S
Ear, Nose, Throat
246d
Cleared
Oct 22, 2019
ClearEdge Balance System
Quadrant Biosciences
Ear, Nose, Throat
299d
Cleared
Aug 16, 2019
EQ Balance
Upright Science, Inc.
Ear, Nose, Throat
148d
Cleared
Apr 02, 2018
K-D Balance
King-Devick Technologies, Inc.
Ear, Nose, Throat
123d
Cleared
Sep 20, 2012
VESTIBULAR ANALYSIS APPARATUS
Capacity Sports, LLC
Ear, Nose, Throat
112d
Cleared
Dec 23, 2010
NYDIAG 200
Interacoustics A/S
Ear, Nose, Throat
125d
Cleared
Apr 07, 2009
VERTIGONE BPPV GOGGLE
Vertigone, Inc.
Ear, Nose, Throat
209d
Cleared
Sep 19, 2008
DIZZYFIX
Clearwater Clinical Limited
Ear, Nose, Throat
105d
Cleared
Jun 20, 2008
EPLEY OMNIAX
Vesticon
Ear, Nose, Throat
339d
Cleared
Apr 18, 2007
KOREBALANCE (KINESTHETIC ABILITY TRAINER)
Sportkat, LLC
Ear, Nose, Throat
37d
Cleared
Feb 26, 2007
BALANCE REHABILITATION UNIT (BRU)
Medicaa (Uruguay) S.A.
Ear, Nose, Throat
48d
Cleared
Oct 05, 1998
VMT SYSTEM
Target Health, Inc.
Ear, Nose, Throat
525d
Cleared
Feb 27, 1989
BALANCE SYSTEM
Chattanooga Group, Inc.
Ear, Nose, Throat
91d
About Product Code LXV - Regulatory Context
510(k) Submission Activity
22 total 510(k) submissions under product code LXV since 1977, with 22 receiving FDA clearance (average review time: 154 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.