Cleared Traditional

K253638 - xStep (xStep) (FDA 510(k) Clearance)

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

K253638 · Spinex, Inc. · Physical Medicine device
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Apr 2026
Decision
152d
Days
Class 2
Risk

K253638 is an FDA 510(k) clearance for the xStep (xStep). Classified as Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation (product code SDO), Class II - Special Controls.

Submitted by Spinex, Inc. (Fremont, US). The FDA issued a Cleared decision on April 20, 2026 after a review of 152 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5851 - 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 Spinex, Inc. devices

Submission Details

510(k) Number K253638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2025
Decision Date April 20, 2026
Days to Decision 152 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
37d slower than avg
Panel avg: 115d · This submission: 152d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code SDO Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5851
Definition A Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation Is A Device That Can Be Programmed To Apply An Electrical Current Via Electrodes On A Patient's Skin Over The Spine To Improve Muscle Strength And Sensation After Neurological Deficit.
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.