Cleared Traditional

K183152 - Phoenix (FDA 510(k) Clearance)

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

K183152 · Us Bionics, Inc. (Dba Suitx) · Physical Medicine device
Apr 2019
Decision
154d
Days
Class 2
Risk

K183152 is an FDA 510(k) clearance for the Phoenix. Classified as Powered Exoskeleton (product code PHL), Class II - Special Controls.

Submitted by Us Bionics, Inc. (Dba Suitx) (Emeryville, US). The FDA issued a Cleared decision on April 17, 2019 after a review of 154 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3480 - the FDA physical medicine 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 Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

Submission Details

510(k) Number K183152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2018
Decision Date April 17, 2019
Days to Decision 154 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 151d · This submission: 154d
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 Physical Medicine devices follow this clearance model.