LXM

FDA Product Code LXM: Manipulator, Plunger-like Joint

Leading manufacturers include Kinetic Technology, Inc., Spinalight, Inc. and Activator Methods International, Ltd..

32
Total
32
Cleared
189d
Avg days
1988
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Manipulator, Plunger-like Joint Devices (Product Code LXM)

32 devices
1–24 of 32
Cleared Feb 15, 2024
SONIK MONARK 100
K234036
Neuro Spinal Innovation, Inc.
Physical Medicine · 56d
Cleared Dec 21, 2019
Spinalytics
K192629
Optima Health Solutions International Corp.
Neurology · 89d
Cleared Jun 20, 2018
Atlas Percussion Adjusting Instrument
K172536
Spinalight, Inc.
Physical Medicine · 302d
Cleared Nov 04, 2016
VSTAAR AdjusteR
K160278
Spinal Acoustics, LLC
Physical Medicine · 276d
Cleared Jan 23, 2014
KHAN KINETIC TREATMENT (KKT-M2)
K130666
Optima Health Solutions International Corporation
Physical Medicine · 317d
Cleared Mar 06, 2012
ACTIVATOR V-E
K112606
Activator Methods International, Ltd.
Physical Medicine · 180d
Cleared Aug 13, 2008
MAX ADJUSTING INSTRUMENT
K082218
Manna Omni International, Inc.
Physical Medicine · 7d
Cleared Apr 11, 2008
IMPULSE IQ ADJUSTING INSTRUMENT
K080261
Neuromechanical Innovations, LLC
Physical Medicine · 70d
Cleared Oct 23, 2007
ACTIVATOR V SPINAL ADJUSTING INSTRUMENT
K072519
Activator Methods International, Ltd.
Physical Medicine · 46d
Cleared Mar 23, 2006
KHAN KINETIC TREATMENT DEVICE (KKT-M1)
K060043
Optima Health Solutions International, Inc.
Physical Medicine · 76d
Cleared Jun 14, 2005
TECHNOLOGY-ASSISTED MICRO-MOBILIZATION AND REFLEX STIMULATOR (TAMARS)
K050428
Advanced Spinal Technologies, Inc.
Physical Medicine · 116d
Cleared Jan 13, 2003
IMPULSE-ADJUSTING INSTRUMENT, CBP ADJUSTING INSTRUMENT, NEUROMECHANICAL ADJUSTING INSTRUMENT, MODELS 2003
K023462
Neuromechanical Innovations, LLC
Physical Medicine · 90d
Cleared Oct 09, 2002
FRYE ADJUSTING INSTRUMENT
K021238
Frye Health Systems
Physical Medicine · 174d
Cleared Sep 18, 2001
HARRISON HAND HELD ADJUSTING INSTRUMENT
K010851
Harrison Cbp Seminars
Physical Medicine · 181d
Cleared Mar 20, 2001
FS ACTIVATOR III
K003185
Activator Methods International, Ltd.
Physical Medicine · 160d
Cleared Aug 04, 2000
TORQUE INSTRUMENT, MODEL 8500
K001476
Spinalight, Inc.
Physical Medicine · 85d
Cleared Jun 30, 1998
SENSE TECHNOLOGY INC. FRAS, SENSE TECHNOLOGY INC. PULSTAR
K973914
Sense Technology, Inc.
Physical Medicine · 259d
Cleared Feb 18, 1998
JTECH ADJUSTER REFLEX GUN
K974376
J-Tech Medical, Inc.
Physical Medicine · 90d
Cleared Jan 27, 1998
ACTIVATOR II
K973506
Activator Methods, Inc.
Physical Medicine · 133d
Cleared Jan 10, 1997
SMART ADJUSTER (SA201)
K962239
Sigma
Physical Medicine · 213d
Cleared Apr 30, 1996
INTEGRATOR
K950646
Moyco Union Broach, Div., Moyco Technologies, Inc.
Physical Medicine · 442d
Cleared Mar 04, 1996
HAND HELD ATLAS INSTRUMENT
K955540
Spinalight, Inc.
Physical Medicine · 90d
Cleared Jul 15, 1994
ARTHROSTIM MANIPULATOR
K930431
Freeman Procedure Seminars
Physical Medicine · 535d
Cleared Sep 30, 1992
KINETIC TECHNOLOGY POCKET PRECISION ADJUSTOR
K922692
Kinetic Technology, Inc.
Physical Medicine · 118d

About Product Code LXM - Regulatory Context

510(k) Submission Activity

32 total 510(k) submissions under product code LXM since 1988, with 32 receiving FDA clearance (average review time: 189 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.