NAM · Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence
Gastroenterology, Urology · 21 CFR 876.5310 · Class 2
Overview
| Product Code | NAM |
|---|---|
| Device Name | Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence |
| Regulation | 21 CFR 876.5310 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
Identification
A nonimplanted, peripheral electrical continence device is a device that consists of an electrode that is connected by an electrical cable to a battery-powered pulse source. The electrode is placed onto or inserted into the body at a peripheral location and used to stimulate the nerves associated with pelvic floor function to maintain urinary continence. When necessary, the electrode may be removed by the user.
Classification Rationale
Class II, subject to the following special controls:
Special Controls
*Classification.* Class II, subject to the following special controls:(1) That sale, distribution, and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter. (2) That the labeling must bear all information required for the safe and effective use of the device as outlined in § 801.109(c) of this chapter, including a detailed summary of the clinical information upon which the instructions are based.
In addition to the general controls of the act, the Percutaneous SANS Device is subject to the following special controls: (1) The sale, distribution and use of this device are restricted to prescription use in accordance with 21 CFR 801.109. (2) Clinical data are necessary. (3) The labeling must include (a) warnings indicating the need to evaluate the patient during treatment for pain or skin irritation/inflammation; (b) precautions indicating the need to read and understand all directions before using this device; (c) specific instructions to describe proper patients set-up prior to the start of treatment, including proper placement of the electrodes; (d) stimulation parameters and duration and frequency of treatments in accordance with the protocol used during clinical trial; and (e) a summary of the clinical data collected including a listing of adverse events reported.
Recent Cleared Devices (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K220454 | Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application | Avation Medical, Inc. | Apr 3, 2023 | SESE |
| K192731 | ZIDA Wearable Neuromodulation System | Exodus Innovations | Mar 19, 2021 | SESE |
| K132561 | NURO NEUROMODULATION SYSTEM | Advanced Uro-Solutions, Inc. | Nov 5, 2013 | SESE |
| K101847 | URGENT PC STIMULATOR; URGENT PC LEAD SET | Uroplasty, Inc. | Oct 21, 2010 | SESE |
| K071822 | URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200 AND UPC250-12 | Uroplasty, Inc. | Aug 20, 2007 | SESE |
| K061333 | URGENT PC NEUROMODULATION SYSTEM, MODELS UPC200-A AND UPC250-12 | Uroplasty, Inc. | Jul 3, 2006 | SESE |
| K052025 | URGENT PC NEUROMODULATION SYSTEM | Uroplasty, Inc. | Oct 17, 2005 | SESE |
| DEN000002 | UROSURGE PERCUTANEOUS SANS (STOLLER AFFERENT NERVE STIMULATOR) DEVICE | Urosurge, Inc. | Feb 9, 2000 | DENG |
Top Applicants
- Uroplasty, Inc. — 4 clearances
- Advanced Uro-Solutions, Inc. — 1 clearance
- Avation Medical, Inc. — 1 clearance
- Exodus Innovations — 1 clearance
- Urosurge, Inc. — 1 clearance
