Cleared Traditional

K201539 - Keeogo Dermoskeleton System

K201539 is the FDA 510(k) clearance for Keeogo Dermoskeleton System by B-Temia, Inc.. It is a Class 2 Neurology device (product code PHL) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K201539 · B-Temia, Inc. · Neurology device
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Sep 2020
Decision
92d
Days
Class 2
Risk

K201539 is an FDA 510(k) clearance for the Keeogo Dermoskeleton System. Classified as Powered Exoskeleton (product code PHL), Class II - Special Controls.

Submitted by B-Temia, Inc. (St-Augustin-De-Desmaures, CA). The FDA issued a Cleared decision on September 9, 2020 after a review of 92 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 B-Temia, Inc. devices

Submission Details

510(k) Number K201539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2020
Decision Date September 09, 2020
Days to Decision 92 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
56d faster than avg
Panel avg: 148d · This submission: 92d
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

Covington & Burling, Llp
Kristin Davenport

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.

Regulatory Peers - PHL Powered Exoskeleton

All 16
Devices cleared under the same product code (PHL) and FDA review panel - the closest regulatory comparables to K201539.
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