Product Code: LXM FDA unclassified

Manipulator, Plunger-Like Joint

Unknown

The Plunger-Like Joint Manipulator (product code LXM) is a physical medicine device used to apply controlled force to joints for manipulative therapy, typically in chiropractic or osteopathic practice. It is currently unclassified (Class U) with no assigned regulation number or formal medical specialty, and is reviewed under the Physical Medicine (PM) panel. As an unclassified device, its regulatory status has not been fully determined. It is not flagged as an implant or life-sustaining device.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: LXM
Device Class: FDA unclassified
Medical Specialty: Unknown
Review Panel: PM
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

Unclassified Reason

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 32 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K234036	SONIK MONARK 100	Feb 15, 2024	Substantially Equivalent	Neuro Spinal Innovation, Inc.
K192629	Spinalytics	Dec 21, 2019	Substantially Equivalent	Optima Health Solutions International Corp.
K172536	Atlas Percussion Adjusting Instrument	Jun 20, 2018	Substantially Equivalent	Spinalight, Inc.
K160278	VSTAAR AdjusteR	Nov 04, 2016	Substantially Equivalent	Spinal Acoustics, LLC
K130666	KHAN KINETIC TREATMENT (KKT-M2)	Jan 23, 2014	Substantially Equivalent	Optima Health Solutions International Corporation
K112606	ACTIVATOR V-E	Mar 06, 2012	Substantially Equivalent	Activator Methods International, Ltd.
K082218	MAX ADJUSTING INSTRUMENT	Aug 13, 2008	Substantially Equivalent	Manna Omni International, Inc.
K080261	IMPULSE IQ ADJUSTING INSTRUMENT	Apr 11, 2008	Substantially Equivalent	Neuromechanical Innovations, LLC
K072519	ACTIVATOR V SPINAL ADJUSTING INSTRUMENT	Oct 23, 2007	Substantially Equivalent	Activator Methods International, Ltd.
K060043	KHAN KINETIC TREATMENT DEVICE (KKT-M1)	Mar 23, 2006	Substantially Equivalent	Optima Health Solutions International, Inc.
K050428	TECHNOLOGY-ASSISTED MICRO-MOBILIZATION AND REFLEX STIMULATOR (TAMARS)	Jun 14, 2005	Substantially Equivalent	Advanced Spinal Technologies, Inc.
K023462	IMPULSE-ADJUSTING INSTRUMENT, CBP ADJUSTING INSTRUMENT, NEUROMECHANICAL ADJUSTING INSTRUMENT, MODELS 2003	Jan 13, 2003	Substantially Equivalent	Neuromechanical Innovations, LLC
K021238	FRYE ADJUSTING INSTRUMENT	Oct 09, 2002	Substantially Equivalent	Frye Health Systems
K010851	HARRISON HAND HELD ADJUSTING INSTRUMENT	Sep 18, 2001	Substantially Equivalent	Harrison Cbp Seminars
K003185	FS ACTIVATOR III	Mar 20, 2001	Substantially Equivalent	Activator Methods International, Ltd.
K001476	TORQUE INSTRUMENT, MODEL 8500	Aug 04, 2000	Substantially Equivalent	Spinalight, Inc.
K973914	SENSE TECHNOLOGY INC. FRAS, SENSE TECHNOLOGY INC. PULSTAR	Jun 30, 1998	Substantially Equivalent	Sense Technology, Inc.
K974376	JTECH ADJUSTER REFLEX GUN	Feb 18, 1998	Substantially Equivalent	J-Tech Medical, Inc.
K973506	ACTIVATOR II	Jan 27, 1998	Substantially Equivalent	Activator Methods, Inc.
K962239	SMART ADJUSTER (SA201)	Jan 10, 1997	Substantially Equivalent	Sigma
K950646	INTEGRATOR	Apr 30, 1996	Substantially Equivalent	Moyco Union Broach, Div., Moyco Technologies, Inc.
K955540	HAND HELD ATLAS INSTRUMENT	Mar 04, 1996	Substantially Equivalent	Spinalight, Inc.
K951217	ATLAS ORTHOGONAL PERCUSSION INSTTUMENT	Nov 21, 1995	Substantially Equivalent	Sweat Chiropractic Clinic
K946258	MODEL 8000 ATLAS C-1 ORTHOGONAL ADJUSTING INSTRUMENT	Nov 20, 1995	Substantially Equivalent	Spinalight, Inc.
K944369	NEW-STIM SPINAL ADJUSTMENT INSTRUMENT	Apr 26, 1995	Substantially Equivalent	Lawrence E. Newsum, DC
K940085	FORCE RECORDING AND ANALYSIS SYSTEM, MODEL 01	Dec 07, 1994	Substantially Equivalent	Sense Technology, Inc.
K930431	ARTHROSTIM MANIPULATOR	Jul 15, 1994	Substantially Equivalent	Freeman Procedure Seminars
K922695	KINETIC TECHNOLOGY PRECISION ADJUSTOR MOD. SHLCP-5	Sep 30, 1992	Substantially Equivalent	Kinetic Technology, Inc.
K922694	KINETIC TECHNOLOGY PRECISION ADUSTOR MODEL SHLCP-4	Sep 30, 1992	Substantially Equivalent	Kinetic Technology, Inc.
K922693	KINETIC TECHNOOGY PRECISION ADJUSTOR MODEL SHLCP-1	Sep 30, 1992	Substantially Equivalent	Kinetic Technology, Inc.
K922692	KINETIC TECHNOLOGY POCKET PRECISION ADJUSTOR	Sep 30, 1992	Substantially Equivalent	Kinetic Technology, Inc.
K870910	PRECISION SPINAL ADJUSTER MODEL 115	Apr 26, 1988	Substantially Equivalent	Kinetic Technology, Inc.