EASYWELL TENS System TENS and Heat, EASYWELL TENS System TENS only

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Easywell Biomedicals, Inc. Arthur Chen Quality Assurance Manager Suite 2, 2f, No.9, Jhanye 1 Rd. Hsinchu Science Park Hsinchu. TW Re: K163166 Trade/Device Name: Easywell TENS System (TENS only), Easywell TENS System (TENS and Heat) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH Dated: July 11, 2017 Received: July 13, 2017 Dear Arthur Chen: 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. Iisting 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 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must 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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely, Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## K163166 - 510(k) Summary #### I. SUBMITTER EASYWELL BIOMEDICALS INC. Suite 2, 2F, No.9, Jhanye 1st Rd., Hsinchu Science Park, 30078 Hsinchu, TAIWAN Phone:+886-3-666-9596 FAX: +886-3-666-9697 Contact Person: Richard Hsieh Date:Oct. 04, 2016 #### II. DEVICE Trade/Device Name: Easywell TENS System (TENS only), Easywell TENS System (TENS and Heat) Common Name: Transcutaneous Electrical Nerve Stimulator (TENS) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulation Class: Class II Product Code: NUH ### III. PREDICATE DEVICE Omron: Heat Pain Pro (K160115 ) #### IV. DEVICE DESCRIPTION The EASYWELL TENS System is a Transcutaneous Electrical Nerve Stimulation (TENS) set consisting of a stimulator console, an electrode patch, gel pads and an AC/DC adaptor. used for pain relief. There are two models available over-the-counter- (1) TENS only, and (2) a combination of TENS and heat for a warming sensation up to 41.0℃ (105.8°F). The TENS session lasts 15 minutes with 3 stages of varying frequencies. The stimulator console is wearable, weights 32g, with one micro-USB port and one LED light indicator. It has two buttons- "+" button to turn on the stimulator console and to increase the TENS intensity level by 1 (10 intensity levels); "." button to decrease the TENS intensity or turn off the stimulator console when it's pressed for 3 seconds. The green LED light is lit up when the stimulator console is activated. The AC/DC adaptor can be connected to the micro-USB port to recharge the Li-ion battery. The electrode patch is covered by polyester and nylon blended textile and can be connected {3}------------------------------------------------ to the stimulator console via connectors. Patches with varying shapes and sizes are available to fit different and anatomical positions. Carbon fiber is embedded between the electrode and textile to provide heat conductance and far infrared radiation (model EETTA00 and EETTL00 to provide TENS and heat). The gel pads are applied to the electrode surface. They are directly in contact with the skin and made from medical grade electrically conductive hydrogel. Thev comply with ISO 10993-5 biological evaluation of medical devices- Part 5: Tests for in vitro cytotoxicity and ISO 10993-10 biological evaluation of medical devices- Part 10: tests for irritation and skin sensitization. The AC/DC adapter is medical graded which complies with IEC 60601-1 and IEC 60601-1-2 #### INTENDED USE V. The relief of pain associated with sore or aching muscles due to strain from exercise or normal household work activities. ## VI. CONFORM STANDARDS EASYWELL TENS System conforms to the following standard: - 1. AAMI NS4: 2013 Transcutaneous electrical nerve stimulators - 2. IEC 60601-1:2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance - 3. IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests - 4. IEC 60601-1-11:2015 Medical electrical equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment - 5. IEC 60601-2-10: 2012 Medical electrical equipment Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators - 6. ISO 10993-1: 2009 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process - 7. ISO 10993-5: 2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity - 8. ISO 10993-10: 2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization - 9. IEC 62304: 2006 Medical device software -- Software life cycle processes - 10. EN/ISO 14971: 2012 Medical devices. Application of risk management to medical devices {4}------------------------------------------------ 11. IEC/EN 62133:2013 Safety Test Standard of Li-Ion Cell and Battery 12. UN38.3 Testing-Safety Precautions for the Transportation of Lithium Batteries VII. Similarities/Differences of the proposed candidate device when compared to the predicate Omron Heat Pain Pro (K160115) The subject EASYWELL TENS System is substantially equivalent to the predicate Heat Pain Pro (K160115) marketed by Omron Healthcare, Inc. with similar indications for use. The subject EASYWELL TENS System is intended for pain relief with sore or aching due to exercise or normal household work activities. The predicate Heat Pain Pro is intended for relief of pain associated with sore or aching, muscles of the lower back, arms, legs, shoulder, or foot due to strain from exercise or normal household work activities. Both the subject EASYWELL TENS System and predicate Heat Pain Pro are available Over-the-Counter (OTC). Both the subject EASYWELL TENS System and the predicate Heat Pain Pro have similar design specifications. Both use microprocessor technology to control the device and use Lithium-Ion battery as the power source. Both are rechargeable, can automatic shut off, and use the electrode patch with hydrogel. Both the subject EASYWELL TENS System and the predicate Heat Pain Pro have similar output parameters. Both have 1 output channel. The subject EASYWELL TENS System provides TENS therapy on models EETTA00 and EETTL00, and, provides TENS therapy with heat on models EETTA01 and EETTL01; the predicate Heat Pain Pro provides TENS therapy and TENS therapy alternating heat. Both have similar heat temperature range, the subject EASYWELL TENS System conducts heat at maximum 41°C on models EETTA01 and EETTL01 and the predicate Heat Pain Pro conducts heat at maximum 43°C. Both have biphasic rectangular waveform shape. The subject EASYWELL TENS System has timer range 15 minutes and it's repeatable to extend the range, the predicate Heat Pain Pro has timer range 30 minutes. The subject EASYWELL TENS System and the predicate Heat Pain Pro comply with the same standards including IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11 and IEC 60601-2-10. The subject EASYWELL TENS System also complies with AMMI NS4. The similarities between the subject EASYWELL TENS System and the predicate Heat Pain Pro are compared in table 1. {5}------------------------------------------------ | Feature | Subject | Predicate | | | |--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|---------------------------------| | 510(k) Number | - | K160115 | | | | Manufacturer | EASYWELL Biomedicals, Inc. | Omron<br>Healthcare, Inc. | | | | Trade Name | EASYWELL TENS System | Omron Heat<br>Pain Pro | | | | Model Name | EETTA00<br>EETTL00<br>(TENS Only) | EETTA01<br>EETTL01<br>(TENS and Heat) | PM311 | | | Indications for Use | The EASYWELL TENS System is<br>intended for:<br>The relief of pain associated with sore or<br>aching muscles due to strain from<br>exercise or normal household work<br>activities. | The Omron<br>Heat Pain Pro is<br>intended for:<br>The relief of<br>pain associated<br>with sore or<br>aching, muscles<br>of the lower<br>back, arms, legs,<br>shoulder, or foot<br>due to strain<br>from exercise or<br>normal<br>household work<br>activities. | | | | Type of Use | Over-the-Counter (OTC) | Over-the-Count<br>er (OTC) | | | | Design<br>Specification | Controller | Microprocessor | Microprocessor | | | | Power Source | Lithium-Ion battery | Lithium-Ion<br>battery | | | | Rechargeable | Yes | Yes | | | | Automatic Shut Off | Yes | Yes | | | | Electrode Patch/<br>Gel Pad | Electrode Patch with Hydrogel | Electrode Patch<br>with Hydrogel | | | Output<br>Parameter | Number of output<br>channels | 1 Channel | 1 Channel | | | | Output Modes | TENS Therapy<br>only | TENS Therapy with<br>HEAT | | | | Heat Temperature | N.A. | 41°C Maximum | | | | Waveform Shape | Biphasic Rectangular | Biphasic<br>Rectangular | | | | Timer Range | 15 minutes | 30 minutes | | | Compliance with Standards | IEC60601-1<br>IEC60601-1-2 | IEC60601-1<br>IEC60601-1-2 | | | | | | | IEC 60601-1-11<br>IEC60601-2-10<br>AAMI NS4 | IEC 60601-1-11<br>IEC60601-2-10 | | Performance<br>and<br>Specifications | Max.<br>Output<br>Voltage | @500Ω | 58.8V | 67.2V | | | | @2KΩ | 94V | 86.0V | | | | @10KΩ | 119V | 95.9V | | | Max.<br>Output<br>Current | @500Ω | 117.6mA | 134.2mA | | | | @2KΩ | 45.5mA | 45.0mA | | | | @10KΩ | 11.9mA | 9.6mA | | | Duration of primary phase | | 132μs | 32μs | | | Pulse Duration@500Ω | | 220μs | 96μs | | | Frequency | | 2.2 to 34.7Hz | 1 to 99Hz | | | Net Charge @500Ω (per pulse) | | 0μC | 0μC | | | Maximum Phase Charge @500Ω | | 15.5μC | 4.3μC | | | Active Surface Area for each Electrode (cm²) | | 1) EW-P000-G Standard 30<br>2) EW-P000-L Lower Back 60 | 25 | | | | | | | | | Maximum Current for each Electrode @500Ω(mA) | | 1) EW-P000-G Standard 117.6<br>2) EW-P000-L Lower Back 117.6 | 134.2 | | | | | | | | | Maximum Charge Density for each Electrode @500Ω (mA/cm²) | | 1) EW-P000-G Standard 3.92<br>2) EW-P000-L Lower Back 1.96 | 5.38 | | | | | | | | | | | | | | | Maximum Power Density for each Electrode @500Ω (mW/cm²) | | 1) EW-P000-G Standard 230.5<br>2) EW-P000-L Lower Back 115.2 | 361.3 | | | | | | | Table 1 Comparison with the predicate Heat Pain Pro (K160115) {6}------------------------------------------------ ## Substantial Equivalence: EASYWELL TENS System has the same intended use, principles of operation, and similar technological characteristics as predicate devices. Moreover, bench testing contained in this submission and clinical evaluation report supplied demonstrates that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the EASYWELL TENS System is substantially equivalent to the predicate devices. {7}------------------------------------------------ # Please wait... If this message is not eventually replaced by the proper contents of the document, your PDF viewer may not be able to display this type of document. You can upgrade to the latest version of Adobe Reader for Windows®, Mac, or Linux® by visiting http://www.adobe.com/go/reader_download. For more assistance with Adobe Reader visit http://www.adobe.com/go/acrreader. Windows is either a registered trademark of Microsoft Corporation in the United States and/or other countries. Mac is a trademark of Apple Inc., registered in the United States and other countries. 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