Cleared Traditional

K143458 - Neurosplint

K143458 is an FDA 510(k) clearance for Neurosplint, manufactured by Neurospectrum, LLC. The device is a Class 1 Physical Medicine device with product code IQI cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K143458 · Neurospectrum, LLC · Physical Medicine device
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Aug 2015
Decision
252d
Days
Class 1
Risk

K143458 is an FDA 510(k) clearance for the Neurosplint. Classified as Orthosis, Limb Brace (product code IQI), Class I - General Controls.

Submitted by Neurospectrum, LLC (Rancho Mirage, US). The FDA issued a Cleared decision on August 13, 2015 after a review of 252 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3475 - the FDA physical medicine device framework. 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.

View all Neurospectrum, LLC devices

FDA 510(k) Submission Details - K143458

510(k) Number K143458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2014
Decision Date August 13, 2015
Days to Decision 252 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
137d slower than avg
Panel avg: 115d · This submission: 252d
Pathway characteristics
Predicate-based equivalence.

IQI Device Classification - Class 1, General Controls

Product Code IQI Orthosis, Limb Brace
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3475
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IQI Orthosis, Limb Brace

All 22
Devices cleared under the same product code (IQI) and FDA review panel - the closest regulatory comparables to K143458.
ACCUFLEX DYNAMIC ELBOW ORTHOSIS
K926391 · Regulatory & Marketing Services, Inc. · Jul 1993
ADJUSTABLE POLYCENTRIC ELBOW HINGE
K831542 · Fred Sammons, Inc. · Jun 1983
VARIOUS SUPPORTS AND SPLINTS
K823812 · Danek Medical, Inc. · Jan 1983
ROTATION BOOT
K823160 · Warm & Form, Orthopedic Materials · Nov 1982
ORTHOTIC FABRICATION ACCESSORIES
K821640 · Fred Sammons, Inc. · Jun 1982
OBTHOSES
K821641 · Fred Sammons, Inc. · Jun 1982