Cleared Traditional

HAL for Medical Use (Lower Limb Type)

K171909 · Cyberdyne, Inc. · Neurology
Dec 2017
Decision
174d
Days
Class 2
Risk

About This 510(k) Submission

K171909 is an FDA 510(k) clearance for the HAL for Medical Use (Lower Limb Type), a Powered Exoskeleton (Class II — Special Controls, product code PHL), submitted by Cyberdyne, Inc. (Tsukuba, JP). The FDA issued a Cleared decision on December 17, 2017, 174 days after receiving the submission on June 26, 2017. This device falls under the Neurology review panel. Regulated under 21 CFR 890.3480.

Submission Details

510(k) Number K171909 FDA.gov
FDA Decision Cleared SESE
Date Received June 26, 2017
Decision Date December 17, 2017
Days to Decision 174 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.