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  1. Recently-Approved Devices

Xstim Spine Fusion Stimulator – P230025

Xstim Spine Fusion Stimulator System Components and Example of intended placement of electrode pads when used on the low back.

This is a brief overview of information related to the FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for the FDA’s approval.

Product Name: Xstim Spine Fusion Stimulator
PMA Applicant: Xstim Inc.
Address: Xstim Inc.,1320 Greenway Drive, Suite 200-F, Irving, Texas 75038 USA
Approval Date: February 9, 2024
Approval Letter: Approval Order

What is it?

The Xstim Spine Fusion Stimulator is a bone growth stimulator (BGS) device intended be used on the lower back. The device components include a controller for creating signals, a belt clip, a rechargeable lithium-ion battery pack and charging unit, controller cables, hydrogel electrode pads that stick to the skin, optional electrode covers, including some for use only when showering, and a carry case.

 
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