Cleared Traditional

Phoenix (K183152) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through predicate-based substantial equivalence.

K183152 · Us Bionics, Inc. (Dba Suitx) · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Us Bionics, Inc. (Dba Suitx) devices

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 115d · This submission: 154d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Physical Medicine 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.

Clinical Evidence

ClinicalTrials.gov
NCT03175055 Completed Interventional Industry-sponsored

Phoenix Exoskeleton for SCI Users

Phoenix Exoskeleton Clinical Study

40
Patients (actual)
4
Sites
Other
Purpose
Open label
Masking
Condition studied SCI - Spinal Cord Injury
Study design Single group
Eligibility All sexes · 18 Years+
Sponsor US Bionics (industry)
Started 2017-06-01 → Primary completion 2018-05-31
Primary outcome
Timed Up and Go (TUG)
Secondary outcome
Surface Walk Test
Study completed - no results published. This trial concluded in 2018 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - PHL Powered Exoskeleton

All 23
Devices cleared under the same product code (PHL) and FDA review panel - the closest regulatory comparables to K183152.
Atalante X
K250904 · Wandercraft SAS · Oct 2025
ReWalk® 7 Personal Exoskeleton (50-20-0005)
K241822 · Rewalk Robotics Ltd. Dba Lifeward · Mar 2025
Medical HAL Lower Limb Type (HAL-ML)
K233695 · Cyberdyne, Inc. · May 2024
Atalante X
K232077 · Wandercraft SAS · Dec 2023
ReWalk P6.0
K221696 · Re Walk Robotics , Ltd. · Mar 2023
Atalante
K221859 · Wandercraft SAS · Dec 2022