Cleared Traditional

Indego(R)

K173530 · Parker Hannifin Corporation · Neurology

Jan 2018

Decision

77d

Days

Class 2

Risk

About This 510(k) Submission

K173530 is an FDA 510(k) clearance for the Indego(R), a Powered Exoskeleton (Class II — Special Controls, product code PHL), submitted by Parker Hannifin Corporation (Macedonia, US). The FDA issued a Cleared decision on January 31, 2018, 77 days after receiving the submission on November 15, 2017. This device falls under the Neurology review panel. Regulated under 21 CFR 890.3480.

Submission Details

510(k) Number	K173530 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 15, 2017
Decision Date	January 31, 2018
Days to Decision	77 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.