WITOUCH PRO

K120398 · Hollywog, LLC · GZJ · Aug 16, 2012 · Neurology

Device Facts

• Record ID: K120398
• Device Name: WITOUCH PRO
• Applicant: Hollywog, LLC
• Product Code: GZJ · Neurology
• Decision Date: Aug 16, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use is to provide analgesic electrical stimulus to reduce the perception of back pain by electrically stimulating peripheral nerves across the skin (transcutaneously).

Device Story

WiTouch Pro is a battery-powered Transcutaneous Electrical Nerve Stimulator (TENS) for back pain management. Device consists of a current generator with integral electrodes and replaceable hydrogel pads; adheres directly to patient's back skin. Operated by patient via wireless radio frequency (RF) remote control to adjust intensity and power. Device delivers pulsed biphasic electrical stimulus to peripheral nerves to reduce pain perception. Features include automatic shut-off and low battery indicator. Designed for home use; provides non-invasive analgesic treatment. Output characteristics are controlled to maintain power density below 0.25 W/cm² to prevent thermal burns.

Clinical Evidence

Bench testing only. Device performance verified against recognized standards including IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-1-4 (programmable systems), IEC 60601-2-10 (nerve stimulators), and ISO 10993 series (biocompatibility/cytotoxicity/sensitization).

Technological Characteristics

Materials: Silicone and ABS housing, carbon rubber electrodes, hydrogel pads. Energy: 1.5VDC (2-AAA batteries). Waveform: Pulsed biphasic, square shape. Connectivity: Wireless RF transceiver (ISM band). Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-10, ISO 10993-1/5/10. Dimensions: 7.5" x 3.5" x 0.7".

Indications for Use

Indicated for symptomatic relief and management of chronic intractable back pain, relief of upper and lower back pain associated with arthritis, and adjunctive treatment for post-surgical and post-trauma acute back pain.

Regulatory Classification

Identification

A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.

Predicate Devices

• Empi SELECT® (K061650)
• Staodyn® Max Preset TENS (K061516)

Submission Summary (Full Text)

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#### 510(k) Summary per 21 CFR 807.92

# 510(k) # K120398

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AUG 1 6 2012

#### Hollywog, LLC 510(k) SUBMITTER: 2830 Amnicola Highway Chattanooga, TN 37406

#### ESTABLISHMENT REGISTRATION: 3008585473

Michael W. Treas. CONTACT: Chief Compliance Officer

DATE PREPARED: August 15, 2012

PROPRIETARY NAME: WiTouch™ Pro

PANEL: Neurology

REGULATION NUMBER: CFR Title 21, 882.5890

CLASSIFICATION: Class II

PRODUCT CODES: GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief); NYN (Stimulator, Electrical, Transcutaneous, For Arthritis)

- COMMON NAME: Transcutaneous electrical nerve stimulator for pain relief.
#### Description:

The WiTouch™ Pro medical device is a Transcutaneous Electrical Nerve Stimulator (TENS) used to reduce the perception of pain by electrically stimulating peripheral nerves across the skin (transcutaneously). The design consists of a battery powered current generator with integral electrodes and replaceable electrical dispersive hydrogel pads (gel-pads). One side of the adhesive gel-pad adhere to the integral electrode, and the other side adhere the device to the healthy intact skin of the patient's back to provide a transcutaneous analgesic electrical stimulus to the painful area.

#### Indications for Use:

The WiTouch" Pro Transcutaneous Electrical Nerve Stimulator Device is used for the symptomatic relief and management of chronic intractable back pain and relief of pain of the upper and lower back associated with arthritis. It is also used for adjunctive treatment for post-surgical and post-trauma acute back pain.

#### Intended Use:

The intended use is to provide analgesic electrical stimulus to reduce the perception of back pain by electrically stimulating peripheral nerves across the skin (transcutaneously).

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## 510(k) Summary per 21 CFR 807.92

## 510(k) # K120398

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#### Accessories:

The device utilizes hydrogel pads) for achieving the indications for use and intended use. The composition of the gel-pads is common materials found in the electrode industry. The uniqueness of the gel-pads is in the shape. The maximum average power density of the electrodes with the gel-pads applied is less than 0.25 watts per square centimeter of electrode conductive surface area to reduce the risk of thermal burns which is consistent with the referenced predicate devices.

| 510(k) # | Predicate Proprietary<br>Trade Name | Predicate Regulation, Classification, and Product Code(s) | |
|-------------------------------------------------------------------------------------------------------------------|-------------------------------------|-----------------------------------------------------------|------------------------------------|
| K061650 | Empi SELECT® | CFR Title 21, Sec. 882.5890, Class II, GZJ, NYN | |
| K061516 | Staodyn® Max Preset TENS | CFR Title 21, Sec. 882.5890, Class II, GZJ, NYN | |
| 510(k) Number | K120398 | K061650 | K061516 |
| Device Name and Model | WiTouch™ Pro | Empi® Select | Staodyn®<br>Max preset TENS |
| Manufacturer | Hollywog | EMPI | Compex Technologies |
| TENS Device Power Source (DC battery) | Battery 1.5VDC<br>(2-Alkaline AAA) | Battery 1.5VDC<br>(3-Alkaline AAA) | Battery 1.5VDC<br>(3-Alkaline AAA) |
| Number of Output Modes | 4 | 4 | 4 |
| Number of Output Channels: Synchronous or Asynchronous? | 1 Channel Asynchronous | 2 Channels Asynchronous | 2 Channels Synchronous |
| Software/Firmware/Microprocessor Control? | Yes | Yes | Yes |
| Automatic Shut Off? | Yes | Yes | Yes |
| User Override Control? | Yes | Yes | Yes |
| Indicator On/Off Status? | Yes | Yes | Yes |
| Display: Low Battery? | Yes | Yes | No |
| Voltage/Current Level? | No | No | No |
| Timer Range (minutes) | 30 | 1 to 30 | 1 to 30 |
| Weight (lbs., oz.) | 4.8 oz.<br>w/ batteries included | 4.9 oz.<br>w/ batteries included | 5.15 oz.<br>w/ batteries included |
| Dimensions (in.) [W x H x D] | 7.5"(W) x 3.5(H)" x<br>0.7"(D) | 2.38"(W) x 1.38"(H) x<br>4.31"(D) | 2.5"(W) x 5.25"(H) x<br>1.0"(D) |
| Housing Material and Construction | Silicone & ABS | Plastic | Plastic |
| Waveform (e.g., pulsed monophasic, biphasic) | Pulsed biphasic | Pulsed biphasic | Pulsed biphasic |
| Shape (e.g., rectangular, spike, rectified sinusoidal) | Square | Square | Square |
| For multiphasic waveforms only: Symmetrical phases? | No | No | Yes |
| Step-1 and Step-3<br>Phase Duration (include units), (state range, if applicable), (both phases, if asymmetrical) | 120μs | 0 to 400μs at 50% peak amplitude | 0 to 300μs |
| Step-2<br>Phase Duration (include units), (state range, if applicable), (both phases, if asymmetrical) | 480μs | 0 to 400μs at 50% peak amplitude | 0 to 300μs |
| Maximum Current Density, (mA/cm², r.m.s.) | 0.12mA@500 Ω | <10mA @500 Ω | <10mA @500 Ω |
| Maximum Average Current (average absolute value), mA | 1.6mA@500 Ω | <10mA @500 Ω | <10mA @500 Ω |
| Maximum Average Power Density, (W/cm²), (using smallest electrode conductive surface area) | 0.00069W/cm2@ 500 Ω | <0.25 W/cm2 at 500 Ω | <0.25 W/cm2 at 500 Ω |

Substantially Equivalent Predicate Devices

The predicate devices utilize flexible wires between the electrical stimulus generator: thus. increases the indications for use to the lower back and to body surfaces with greater ranges of motion (e.g., knee, shoulder, elbow, and hip).

The intended design of the WiTouch" Pro device limits the application for use to the anatomical sites of the upper and lower back. The design includes carbon rubber electrodes that are intended for reuse and are permanently-affixed to a rigid surface of the electrical stimulus generator. The unique connection makes the electrodes integral to the generator. The connection and shape of the electrodes limit application of the device to the contours of the back. These unique characteristics of the integral electrodes are insignificant as it relates to safety and effectiveness, and is not critical to the intended use between the device and the referenced predicate devices.

The referenced predicate devices utilize affixed buttons as the sole method to control the electrical stimulus generator on/off and intensity up/down. The WiTouch™ Pro utilizes an additional method of a wireless remote control radio frequency transceiver to control the electrical stimulus generator on/off and intensity up/down. The transceiver operates in the ISM radio frequency band for wireless medical technology. This uniqueness of controlling the electrical stimulus generator by utilizing a radio frequency transceiver is insignificant as it relates to safety .and effectiveness, and is not critical to the intended use between the device and the referenced predicate devices

The characteristics of the analgesic electrical stimulus output between the device and the referenced predicate devices are substantially equivalent as it relates to safety and effectiveness.

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# 510(k) # K120398

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Technological characteristics and physical properties of the WiTouch Pro device and the referenced predicate devices:

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# 510(k) # K120398

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#### Declarations of Conformity

The device complies with the following FDA recognized standards:

FDA Recognized Number 5-4. IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988 Amendment 1, 1991-11, Amendment 2, 1995. (General)

FDA Recognized Number 5-60, IEC 60601-1-2 Int. 1 Third Edition/I-SH 01:2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests, Interpretation Sheet. (General) .

FDA Recognized Number 5-41. Medical electrical equipment - Part 1-4: General requirements for safety- Collateral standard: Programmable electrical medical systems, edition 1.1. (General)

FDA Recognized Number 17-5. IEC 60601-2-10 1987/Amendment 1 2001. Medical electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators. (Neurology)

FDA Recognition Number 2-156: AAMI/AMSI/ ISO 10993-1:2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. (Biocompatibility)

FDA Recognition Number 2-153 (Electrodes) ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity. (Biocompatibility)

FDA Recognized Standard 2-173 (Electrodes) Recognition Number 2-173: AAMI / ANSI / ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization. (Biocompatibility)

#### Truthful and Accurate Statement

A statement was included in the Premarket Notification attesting to the truthfulness and accuracy of the information provided.

#### Further Information

In the event that additional information is required, please contact:

Michael W. Treas Chief Compliance Officer Hollywog, LLC 2830 Amnicola Highway Chattanooga, TN 37406

Telephone: [phone] ext. 108 Fax: [phone] E-mail: [e-mail]

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an image of an eagle.

#### Public Health Service

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

AUG 1 6 2012

Hollywog, LLC Mr. Michael Treas Chief Compliance Officer 2830 Amnicola Highway Chattanooga, TN 37406

Re: K120398

Trade/Device Name: WiTouch Pro Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous nerve stimulator, for pain relief Regulatory Class: II Product Code: GZJ, NYN Dated: July 10, 2012 Received: July 12, 2012

Dear Mr. Treas:

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 commerce 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 may be subject to additional controls. Existing major regulations affecting your device can be may of subject to additions, 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 r loase be devilou that I broundan that your device complies with other requirements of the Act that I Drivias intact a and regulations administered by other Federal agencies. You must

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Page 2 – Mr. Michael Treas

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical 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,

Kesia Alexander

Image /page/5/Picture/8 description: The image shows a signature in black ink on a white background. The signature appears to be cursive and somewhat stylized. The signature is illegible, but it seems to start with a loop and ends with a small curve.

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number: K120398

Device Trade Name: WiTouch® Pro

Indications for Use:

The WiTouch® Pro Transcutaneous Electrical Nerve Stimulator Device is used for the symptomatic relief and management of chronic intractable back pain and relief of pain of the upper and lower back associated with arthritis. It is also used for adjunctive treatment for post-surgical and post-trauma acute back pain.

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | |
|-------------------------------------------------|--|
| AND/OR | |
| Over-The-Counter Use<br>(21 CFR 801 Subpart C) | |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) :

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K120398