Altius Battery Charger

Basic Information

• Brand Name: Altius Battery Charger
• Primary DI: 00810118490019
• Version / Model: FG-603-000
• Company Name: Neuros Medical, Inc.
• Labeler DUNS: 829526081
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-12-23
• Public Version: 2
• Public Version Date: 2025-12-15
• Public Version Status: Update
• Public Device Record Key: 3ca216fb-9e09-4b0e-bdf6-53169fbc8362

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
SAZ	Stimulator, Nerve Terminus, Totally Implanted For Chronic Intractable Post-Amputation Pain Of The Lower Limb	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
33658	Implant battery charger	An electronic device intended to be used to wirelessly recharge the batteries of an active implantable device in situ. It is not intended to program or extract data from (read) the implanted device. Battery-powered device types may include a line-powered charger (e.g., docking station); devices intended to hold/stabilise the device during use (e.g., implant battery charger belt/collar) may be included with this device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810118490019	GS1

Premarket Submissions

Submission Number	Supplement Number
P230020	000