Cleared Traditional

Neurosplint

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

About This 510(k) Submission

K143458 is an FDA 510(k) clearance for the Neurosplint, a Orthosis, Limb Brace (Class I — General Controls, product code IQI), submitted by Neurospectrum, LLC (Rancho Mirage, US). The FDA issued a Cleared decision on August 13, 2015, 252 days after receiving the submission on December 4, 2014. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3475.

Submission Details

510(k) Number K143458 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code IQI — Orthosis, Limb Brace
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.3475