Cleared Traditional

K233695 - Medical HAL Lower Limb Type (HAL-ML)

K233695 is an FDA 510(k) clearance for Medical HAL Lower Limb Type (HAL-ML), 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 172-day FDA review.

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

K233695 is an FDA 510(k) clearance for the Medical HAL Lower Limb Type (HAL-ML). Classified as Powered Exoskeleton (product code PHL), Class II - Special Controls.

Submitted by Cyberdyne, Inc. (Tsukuba, JP). The FDA issued a Cleared decision on May 7, 2024 after a review of 172 days - an extended review cycle.

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 - K233695

510(k) Number K233695 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 148d · This submission: 172d
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
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