Cleared Traditional

K201559 - HAL for Medical Use(Lower Limb type)

K201559 is an FDA 510(k) clearance for HAL for Medical Use(Lower Limb type), manufactured by Cyberdyne, Inc.. The device is a Class 2 Neurology device with product code PHL cleared through the Traditional 510(k) pathway after a 114-day FDA review.

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

K201559 is an FDA 510(k) clearance for the HAL for Medical Use(Lower Limb type). Classified as Powered Exoskeleton (product code PHL), Class II - Special Controls.

Submitted by Cyberdyne, Inc. (Tsukuba, JP). The FDA issued a Cleared decision on October 2, 2020 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 890.3480 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cyberdyne, Inc. devices

FDA 510(k) Submission Details - K201559

510(k) Number K201559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 148d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PHL Device Classification - Class 2, Special Controls

Product Code PHL Powered Exoskeleton
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - PHL Powered Exoskeleton

All 16
Devices cleared under the same product code (PHL) and FDA review panel - the closest regulatory comparables to K201559.
EksoNR
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EksoNR
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