Cleared Traditional

K023462 - IMPULSE-ADJUSTING INSTRUMENT, CBP ADJUSTING INSTRUMENT, NEUROMECHANICAL ADJUSTING INSTRUMENT, MODELS 2003

K023462 · Neuromechanical Innovations, LLC · Physical Medicine device

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Jan 2003

Decision

90d

Days

Risk

K023462 is an FDA 510(k) clearance for the IMPULSE-ADJUSTING INSTRUMENT, CBP ADJUSTING INSTRUMENT, NEUROMECHANICAL ADJUS.... Classified as Manipulator, Plunger-like Joint (product code LXM).

Submitted by Neuromechanical Innovations, LLC (Phoenix, US). The FDA issued a Cleared decision on January 13, 2003 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K023462

510(k) Number	K023462 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 15, 2002
Decision Date	January 13, 2003
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

26d faster than avg

Panel avg: 116d · This submission: 90d

Pathway characteristics

Predicate-based equivalence.

LXM Device Classification - Class 0,

Product Code	LXM Manipulator, Plunger-like Joint
Device Class	-

Regulatory Peers - LXM Manipulator, Plunger-like Joint

All 31

Devices cleared under the same product code (LXM) and FDA review panel - the closest regulatory comparables to K023462.

ACTIVATOR V SPINAL ADJUSTING INSTRUMENT

K072519 · Activator Methods International, Ltd. · Oct 2007

KHAN KINETIC TREATMENT DEVICE (KKT-M1)

K060043 · Optima Health Solutions International, Inc. · Mar 2006

TECHNOLOGY-ASSISTED MICRO-MOBILIZATION AND REFLEX STIMULATOR (TAMARS)

K050428 · Advanced Spinal Technologies, Inc. · Jun 2005

FRYE ADJUSTING INSTRUMENT

K021238 · Frye Health Systems · Oct 2002

HARRISON HAND HELD ADJUSTING INSTRUMENT

K010851 · Harrison Cbp Seminars · Sep 2001

FS ACTIVATOR III

K003185 · Activator Methods International, Ltd. · Mar 2001

FDA 510(k) Resources - Physical Medicine

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K023462

Neuromechanical Innovations, LLC

Phoenix, AZ · US

CHRISTOPHER J COLLOCA

Regulatory profile

2 submissions 2 cleared

100% clearance rate · Active in Physical Medicine

View all devices by Neuromechanical Innovations, LLC →

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: January 13, 2003. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: October 2026.

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