FDA.reportPublic FDA data

Altius Battery Charger

Primary DI
00810118490019
Brand
Altius Battery Charger
Company
Neuros Medical, Inc.
Model
FG-603-000
Published
2024-12-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
SAZStimulator, Nerve Terminus, Totally Implanted For Chronic Intractable Post-Amputation Pain Of The Lower Limb

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SAZStimulator, Nerve Terminus, Totally Implanted For Chronic Intractable Post-Amputation Pain Of The Lower LimbUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P230020000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P230020000Altius® Direct Electrical Nerve Stimulation SystemNeuros Medical, Inc.2024-08-26SAZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810118490019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810118490019008101184900198101184900190810118490019

GMDN Terms#

Term, Definition table
TermDefinition
Implant battery chargerAn 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
829526081
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810118490101Altius IPG Accessory KitFG-610-0002025-06-23
00810118490002Altius IPGFG-601-0002024-12-23
00810118490026Altius Patient ControllerFG-604-0002024-12-23
00810118490057Altius Programmer WandFG-606-0002024-12-23
00810118490064Altius Programming Application PCFG-608-0002024-12-23
00810118490071Altius Cuff SmallFG-600-0012024-12-23
00810118490088Altius Cuff MediumFG-600-0022024-12-23
00810118490095Altius Cuff LargeFG-600-0032024-12-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810118490101Altius IPG Accessory KitNeuros Medical, Inc.SAZ2025-06-23
00810118490002Altius IPGNeuros Medical, Inc.SAZ2024-12-23
00810118490026Altius Patient ControllerNeuros Medical, Inc.SAZ2024-12-23
00810118490057Altius Programmer WandNeuros Medical, Inc.SAZ2024-12-23
00810118490064Altius Programming Application PCNeuros Medical, Inc.SAZ2024-12-23
00810118490071Altius Cuff SmallNeuros Medical, Inc.SAZ2024-12-23
00810118490088Altius Cuff MediumNeuros Medical, Inc.SAZ2024-12-23
00810118490095Altius Cuff LargeNeuros Medical, Inc.SAZ2024-12-23