INWAVE

K121820 · Zynex Medical, Inc. · KPI · Aug 24, 2012 · Gastroenterology, Urology

Device Facts

• Record ID: K121820
• Device Name: INWAVE
• Applicant: Zynex Medical, Inc.
• Product Code: KPI · Gastroenterology, Urology
• Decision Date: Aug 24, 2012
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 876.5320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The InWave is intended to provide electrical stimulation and neuromuscular reeducation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress urge and mixed urinary incontinence in women.

Device Story

InWave is a non-implanted electrical continence device; provides electrical stimulation and neuromuscular reeducation to pelvic floor muscles. Used for rehabilitation of weak pelvic floor muscles in women with stress, urge, or mixed urinary incontinence. Device delivers electrical pulses to stimulate muscle contraction; assists in strengthening pelvic floor. Operated by patient under physician prescription. Output consists of electrical stimulation parameters; helps improve muscle control and reduce incontinence symptoms. Clinical benefit includes improved pelvic floor function and reduction in urinary incontinence episodes.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on regulatory review of device characteristics and intended use.

Technological Characteristics

Non-implanted electrical continence device; utilizes electrical stimulation for neuromuscular reeducation. Class II device (21 CFR 876.5320, Product Code KPI).

Indications for Use

Indicated for women suffering from stress, urge, or mixed urinary incontinence requiring pelvic floor muscle rehabilitation via electrical stimulation and neuromuscular reeducation.

Regulatory Classification

Identification

A nonimplanted electrical continence device is a device that consists of a pair of electrodes on a plug or a pessary that are connected by an electrical cable to a battery-powered pulse source. The plug or pessary is inserted into the rectum or into the vagina and used to stimulate the muscles of the pelvic floor to maintain urinary or fecal continence. When necessary, the plug or pessary may be removed by the user. This device excludes an AC-powered nonimplanted electrical continence device and the powered vaginal muscle stimulator for therapeutic use (§ 884.5940).

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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## Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

AUG 2 4 2012

Mr. Jim Arnold OA Manager Zynex Medical, Inc. 9990 Park Meadows Dr. LONE TREE CO 80124

Re: K121820

Trade/Device Name: Non-Implanted Electrical Continence Device, Model InWave Regulation Number: 21 CFR§ 876.5320 Regulation Name: Nonimplanted electrical continence device Regulatory Class: II Product Code: KPI Dated: August 15, 2012 Received: August 15, 2012

Dear Mr. Arnold:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 more prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it your device to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease of as need a determination that your device complies with other requirements of the Act that I Dr has made a avod regulations administered by other Federal agencies. You must of any I cuttated and the Act's requirements, including, but not limited to: registration and listing Comply with an the Pre- Pre (21 CFR Part 801); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin K. Tuchs

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/2/Picture/0 description: The image shows the logo for Zynex Medical. The logo features the word "ZYNEX" in large, bold, sans-serif font, with the word "MEDICAL" in a smaller font size underneath. A curved line arches over the word "ZYNEX", adding a dynamic element to the design. The overall design is simple, clean, and professional.

## Zynex Medical

9990 Park Meadows Dr Lone Tree, CO 80124 Main Office: 800-495-6670 Main Fax: [phone] www.zynexmed.com

## INDICATIONS FOR USE

510(k) Number: K121820

Device Name: Non-Implanted Electrical Continence Device, Model InWave.

Indications for Use:

The InWave is intended to provide electrical stimulation and neuromuscular reeducation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress urge and mixed urinary incontinence in women.

Prescription Use
(Part 21 CFR 801 Subpart D)

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K121820

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