Cleared Traditional

K253638 - xStep (xStep)

K253638 is an FDA 510(k) clearance for xStep (xStep), manufactured by Spinex, Inc.. The device is a Class 2 Physical Medicine device with product code SDO cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K253638 · Spinex, Inc. · Physical Medicine device
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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K253638

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.

SDO Device Classification - Class 2, Special Controls

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.