SW B36104S SURETUNE4 DBS SERVER

SW B36104S SURETUNE4 DBS SERVER
SureTune™ 4 - B36104S

Device Description

A software program intended to assist with the management of an implantable electrical stimulator associated with stimulation of the spinal cord, non-auditory peripheral nerves, brain, and/or muscles; it is not intended to manage hearing assistive implants. It may be intended for use in one or more areas of functionality including: 1) configuration of a variety of electrical pulse parameters (e.g., amplitude, frequency, width) for the provision of periodic electrical stimulation; 2) post-implantation visualization; 3) assessment of programming parameters; 4) collection of patient clinical data.

Environmental Conditions

No Data Available

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: QQC

Device Name: Brain Stimulation Programming Planning Software.

Device Class: 2

Physical State: Software

Definition: The brain stimulation programming planning software is a prescription device intended to assist in planning stimulation programming for implanted brain stimulators.

Submission Type ID: 1

Review Panel: NE

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Software to display modeled stimulation field in the brain.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Brain

Regulation Number: 882.5855

Third Party Flag: N

Medical Specialty: NE

Device Identifiers

Device Id: 00763000421212

Device Type: Direct Marking

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A