Cleared Traditional

HAL for Medical Use(Lower Limb type)

K201559 · Cyberdyne, Inc. · Neurology
Oct 2020
Decision
114d
Days
Class 2
Risk

About This 510(k) Submission

K201559 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 October 2, 2020, 114 days after receiving the submission on June 10, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 890.3480.

Submission Details

510(k) Number K201559 FDA.gov
FDA Decision Cleared SESE
Date Received June 10, 2020
Decision Date October 02, 2020
Days to Decision 114 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.