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510(k) K253638

xStep (xStep) by Spinex, Inc. — Product Code SDO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 2026
Date Received
November 19, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation
Device Class
Class II
Regulation Number
890.5851
Review Panel
PM
Submission Type

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.

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