SW APP A511 GU CLINICIAN EVALUATION

SW APP A511 GU CLINICIAN EVALUATION
N/A - A511

A portable, electrically-powered external device intended to wirelessly change one or more of the operating parameters (the programs) of a wearable peripheral nerve electrical stimulation system pulse generator. It may be a digital device which includes controls (e.g., graphical user interface), integrated software, and a wireless communication transmitter and receiver, or it may contain magnets of different field strengths that transmit commands when proximal to the stimulator. It is typically used during a trial period (<30 days) to validate the therapy. It is intended for use by both a clinician and a patient/layperson (under the guidance of a clinician) in a home or a clinical setting.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: EZW

Device Name: Stimulator, Electrical, Implantable, For Incontinence

Device Class: 3

Physical State: N/A

Definition: PMAs to be filed by 12/26/96 (61 FR 50707 (9/27/96))

Submission Type ID: 2

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: 876.5270

Third Party Flag: N

Medical Specialty: GU

Device Id: 00643169834323

Device Type: Primary

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