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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
136d slower than avg
Panel avg: 116d · 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 Consultant

Nu Device Consulting, LLC
Jean Bigoney

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IQI Orthosis, Limb Brace

All 24
Devices cleared under the same product code (IQI) and FDA review panel - the closest regulatory comparables to K143458.
SENSOR WALK
K052771 · Otto Bock Healthcare LP · May 2006
SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1
K031576 · Surgitech, Inc. · Jul 2003
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
K143458 · Neurosplint
Download PDF Neurospectrum, LLC