Cleared Traditional

Medical HAL Lower Limb Type (HAL-ML)

K233695 · Cyberdyne, Inc. · Neurology
May 2024
Decision
172d
Days
Class 2
Risk

About This 510(k) Submission

K233695 is an FDA 510(k) clearance for the Medical HAL Lower Limb Type (HAL-ML), a Powered Exoskeleton (Class II — Special Controls, product code PHL), submitted by Cyberdyne, Inc. (Tsukuba, JP). The FDA issued a Cleared decision on May 7, 2024, 172 days after receiving the submission on November 17, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 890.3480.

Submission Details

510(k) Number K233695 FDA.gov
FDA Decision Cleared SESE
Date Received November 17, 2023
Decision Date May 07, 2024
Days to Decision 172 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.