Cleared Traditional

Indego

K171334 · Parker Hannifin Corporation · Neurology

Sep 2017

Decision

123d

Days

Class 2

Risk

About This 510(k) Submission

K171334 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 September 8, 2017, 123 days after receiving the submission on May 8, 2017. This device falls under the Neurology review panel. Regulated under 21 CFR 890.3480.

Submission Details

510(k) Number	K171334 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 08, 2017
Decision Date	September 08, 2017
Days to Decision	123 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.