Cleared Traditional

Indego

K152416 · Parker Hannifin Corporation · Neurology
Feb 2016
Decision
184d
Days
Class 2
Risk

About This 510(k) Submission

K152416 is an FDA 510(k) clearance for the Indego, a Powered Exoskeleton (Class II — Special Controls, product code PHL), submitted by Parker Hannifin Corporation (Macedonia, US). The FDA issued a Cleared decision on February 26, 2016, 184 days after receiving the submission on August 26, 2015. This device falls under the Neurology review panel. Regulated under 21 CFR 890.3480.

Submission Details

510(k) Number K152416 FDA.gov
FDA Decision Cleared SESE
Date Received August 26, 2015
Decision Date February 26, 2016
Days to Decision 184 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code PHL — Powered Exoskeleton
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.3480
Definition A Powered Exoskeleton Is A Prescription Device That Is Composed Of An External, Powered, Motorized Orthosis That Is Placed Over A Person's Paralyzed Or Weakened Lower Extremity Limb(s) For Medical Purposes.