ENS 3533 NURO EXTERNAL NEUROSTIMULATOR
NURO™ - 3533
Device Description
An assembly of battery-powered devices designed to treat urinary and/or faecal incontinence with electrical stimuli applied to the sacral nerve via percutaneous tibial nerve stimulation (PTNS). It consists of a pair of electrodes, a needle electrode placed into a leg near the ankle and a surface electrode placed on the same leg, and a pulse generator. It produces an adjustable electrical pulse that travels to the sacral nerve plexus via the tibial nerve. It is operated by healthcare personnel who typically apply a predetermined series of treatment sessions to the patient.
Environmental Conditions
- 106.00
- 50.00
- 80.00
- 20.00
- 131.00
- -4.00
- 55.00
- -20.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: NAM
Device Name: Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
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: N
Target Area: N/A
Regulation Number: 876.5310
Third Party Flag: N
Medical Specialty: GU
Device IdentifiersDevice Id: 00643169654624
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