Cleared Traditional

ExoAtlet-II (K201473) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K201473 · Exoatlet Asia Co. , Ltd. · Neurology device
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Jul 2021
Decision
408d
Days
Class 2
Risk

K201473 is an FDA 510(k) clearance for the ExoAtlet-II. Classified as Powered Exoskeleton (product code PHL), Class II - Special Controls.

Submitted by Exoatlet Asia Co. , Ltd. (Denver, US). The FDA issued a Cleared decision on July 16, 2021 after a review of 408 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Exoatlet Asia Co. , Ltd. devices

Submission Details

510(k) Number K201473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2020
Decision Date July 16, 2021
Days to Decision 408 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
260d slower than avg
Panel avg: 148d · This submission: 408d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Consultant

Acknowledge Regulatory Strategies, LLC
Allison C Komiyama

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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