Xstim

Basic Information

• Brand Name: Xstim
• Primary DI: 00850047248022
• Version / Model: 03-5005
• Company Name: Xstim, Inc
• Labeler DUNS: 119283921
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-08-16
• Public Version: 1
• Public Version Date: 2024-08-26
• Public Version Status: New
• Public Device Record Key: c8673f74-0ece-4fa8-b332-76e3ca8cd37a

Device Description

Xstim, Controller

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LOF	Stimulator, Bone Growth, Non-Invasive	Orthopedic	890.5870	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35463	Patient-worn bone growth electromagnetic stimulator	A battery-powered, body-worn device designed to apply an electrical stimulus directly to bone to promote bone formation (i.e., osteogenesis). It is intended to generate an electromagnetic (EM) field (and its associated induced voltage effects) around a fracture or fusion site; it is not intended to apply an electric current directly to the body. The device is used as an alternative to bone grafting for non-union fractures (a condition in which the ends of a fractured bone fail to unite), and as a spinal fusion adjunct in treating degenerative vertebral diseases. It is also known as an osteogenesis stimulator.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850047248022	GS1

Premarket Submissions

Submission Number	Supplement Number
P230025	000