Everyway OTC EMS, Model EV-805

{0}------------------------------------------------ # 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. Linux is the registered trademark of Linus Torvalds in the U.S. and other countries. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Everyway Medical Instrument Co., Ltd. Paul Hung Official Correspondent 3FL., No. 5, Lane 155, Section 3, Peishen Rd. Shenkeng District, New Taipei City, Taiwan 222 R.O.C. Re: K162744 Trade/Device Name: Everyway OTC EMS, Model EV-805 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: June 27, 2017 Received: July 3, 2017 Dear Paul Hung: 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 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 (reporting of medical device {2}------------------------------------------------ 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 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 {3}------------------------------------------------ 3FI., No. 5, Lane 155, Sec. 3,Beishen Rd., Shenkeng Dist., New Taipei City, Taiwan. ### 510(K) SUMMARY This summary of 510(k) safety and effectiveness information is being prepared in accordance with the requirements of SMDA 1990 and 21 CFR 807.92 at June 15, 2011. The assigned 510(k) number is: K162744. - 1. Submitter's Identifications: Establishment: EVERYWAYMEDICALINSTRUMENTSCO.,LTD. Address: 3Fl., No. 5, Lane 155, Sec. 3, Beishen Rd., Shenkeng Dist, New Taipei City 222, Taiwan Registration Number: 9616877 Operations: Manufacturer Owner/Operator: EVERYWAY MEDICALINSTRUMENTSCO.,LTD. Address : 3FI., No. 5, Lane 155, Sec. 3, Beishen Rd., Shenkeng Dist., New Taipei City 222, Taiwan Contact Person: Robert Tu Phone:886-2-2662-0038 FaxNo.:886-2-2664-5566 e-mail : robert@everyway-medical.com - 2. Name of the Device: Everyway OTC EMS, Model EV-805 - 3. Information of the 510(k) Cleared Device (Predicate Device): K102926: Gemore Muscle Conditioner/Model GM320PE - 4. ClassificationInformation: Trade/Device Name: Everywav OTC EMS. model: EV-805 Requlation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: II Product Code: NGX #### 5. Device Description: The Everyway OTC EMS, model EV-805 is a dual channel powered muscle stimulator intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The various types of muscle work that Everyway OTC EMS can impose on the stimulated muscles are able to improve or facilitate muscle performance by applying an electrical current to electrodes, which are attached on the user's skin. The device measures 101mm(H)x 68mm(W)x21.5mm(D). Its outer housing is made of injection molded thermoplastic resin with the output contact probes consist of chrome-plated spheres. The device is powered by a 9-Volt battery to generate output pulses that is discharged through the two adhesive electrode placed on the patient's skin for treatment and muscle training. The device is operated in such a way that turn on the intensity control knob and adjust the intended intensity or turn off the device during operation through the same control knob. While device is turned on for operation. User then follow the instruction for use to get appropriate stimulation treatment and/or training on the healthy muscles . {4}------------------------------------------------ 3FI., No. 5, Lane 155, Sec. 3,Beishen Rd., Shenkeng Dist., New Taipei City, Taiwan. With the combination of the main device parts as above mentioned , the device can be used as recommended in manual for muscle stimulation and indicated for over-the-counter (OTC) use to improve or facilitate muscle performance - 6. Intended Use: Everyway OTC EMS is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The various types of muscle work that Everyway OTC EMS can impose on the stimulated muscles are able to improve or facilitate muscle performance. Everyway OTC EMS may therefore be considered a technique of muscle training. - 7. Comparison to the 510(k) Cleared Device (Predicate Device): The following features are completely identical among the predicate device and our devices. | Parameter | New Device | Predicate Device | Substantive Equivalency | | |-----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|-----------| | Mode or Program Name or 510k | EV-805 OTC EMS | K102926 | -- | | | Product Code | NGX | NGX | Identical | | | Prescription (Rx) or OTC | ОТС | ОТС | Identical | | | Indication for use (IFU) | Everyway OTC EMS is intended to<br>stimulate healthy muscles in order to<br>improve or facilitate muscle<br>performance. The various types of<br>muscle work that Everyway OTC<br>EMS can impose on the stimulated<br>muscles are able to improve or<br>facilitate muscle performance.<br>Everyway OTC EMS may therefore<br>be considered a technique of<br>muscle training. | The Gemore muscle conditioner,<br>model GM310PE/GM320PE/<br>GM330PE/GM340PE/GM350PE are<br>intended to stimulate healthy muscles<br>in order to improve or facilitate muscle<br>performance.<br>The Gemore muscle conditioner,<br>model GM310PE/GM320PE/<br>GM330PE/GM340PE/GM350PE are<br>not intended to be used in conjunction<br>with therapy or treatment of medical<br>diseases or medical conditions of any<br>kind. None of the Gemore muscle<br>conditioned training programs are<br>designed for injured or ailing muscle<br>and it's use on such muscle in<br>contraindicated. The Gemore muscle<br>conditioner, model<br>GM310PE/GM320PE/<br>GM330PE/GM340PE/GM350PE<br>electrically impulse triggering actions<br>potentials on motoneurones of motor<br>nerves (excitations). The excitations<br>motoneurones are transmitted to the<br>muscle fibers via the motor endplate<br>where they generate mechanical<br>muscle fiber response that correspond<br>to muscle work. Depending on the<br>parameters of the electrical impulses<br>(pulse frequency, duration of<br>contraction, duration of rest, total<br>session duration), different type of<br>muscle work can be imposed on the<br>stimulated muscles. The various types<br>of muscle work that Gemore muscle<br>conditioner can impose on the<br>stimulated muscles are able to<br>improve or facilitate muscle<br>performance. The Gemore muscle<br>conditioner, model<br>GM310PE/GM320PE/<br>GM330PE/GM340PE/GM350PE may<br>therefore be considered a technique of<br>muscle training. | SE* | | | Waveform (e.g., pulsed monophasic), | Biphasic | Biphasic | Identical | | | Shape (e.g., rectangular, spike,<br>rectified sinusoidal) | Rectangular | Rectangular | Identical | | | Maximum Output Voltage (volts)<br>(+/-20%) | 7.66V @500Ω<br>8.2V @2KΩ<br>8.2V @10KΩ | 7.5V @500Ω<br>18.0V @2KΩ<br>23V @10KΩ | SE* | | | Maximum Output Current (mA)<br>(+/-20%) | 15.3mA @500Ω<br>4.1mA @2KΩ<br>0.82mA @10KΩ | 15.0mA @500Ω<br>9.0mA @2KΩ<br>2.3mA @10KΩ | SE* | | | Duration of primary phase (usec) | 210us (single phase) | 200-300us (single phase) | SE* | | | Pulse Duration (usec) | 420us | 600us | SE* | | | Frequency (Hz) [or Rate (pps)] | 2~99Hz | 2~99Hz | Identical | | | For multiphasic<br>waveforms only: | Symmetrical<br>phases? | Yes | Yes | Identical | | Maximum Charge(Microcoulombs<br>per pulse) (if zero, state method of<br>achieving zero net charge for net | 15.75uC | 22.5uC | SE* | | | Maximum Phase Charge(uC) | 15.75uC | 22.5uC | SE* | | | Maximum Current Density | 0.0624mA/cm2 | 0.0716mA/cm2 | SE* | | | Maximum Average Current | 3.119mA | 4.455 mA | SE* | | | Maximum Average Power Density | 2.34mW/cm2 | 2.685mW/cm2 | SE* | | | Pulse per burst | No burst mode | No burst mode | Identical | | | Burst Mode<br>(i.e. pulse trains) | Burst per | No burst mode | No burst mode | Identical | | Bust duration | No burst mode | No burst mode | Identical | | | Duty Cycle | No burst mode | No burst mode | Identical | | | On Time (Second) | 0s, 5s, 6s, All time | 0s, 5s, 6s, All time | Identical | | | Off Time(second) | 0s, 1s, 5s, 10s | 0s, 1s, 5s, 10s | Identical | | {5}------------------------------------------------ 3FL. No. 5. Lane 155. Sec. 3.Beishen Rd., Shenkeng Dist., New Taipei City, Taiwan SE*= Substantially equivalent to the predicate. Please see section 10 for more information. - 8. Discussion of Non-Clinical Tests Verification Activities Performed to Determine the Safety and Performance of the devices are as the followings: Compliance to applicable voluntary standards includes IEC 60601-2-10, as well as IEC 60601-1, IEC60601-1-11 and IEC 60601-1-2 requirement. In addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA software guidance. {6}------------------------------------------------ 3FI., No. 5, Lane 155, Sec. 3,Beishen Rd., Shenkeng Dist., New Taipei City, Taiwan. According to the device features, the testing for the following standards were considered required for the device: - The International Standard IEC 60601-2-10: 2012; Medical Electrical equipment Part 2-10: Particular requirement for the safety of nerve and muscle stimulators. - The International Standard ANSI/AAMI ES 60601-1: 2005 Safety of medical device; Electrical equipment - General safety. - The International Standard IEC 60601-1-2: 2014; Medical Electrical equipment Safety -Electromagnetic Compatibility. - International Standard ISO 10993-1: 2009; Biological evaluation of medical devices -Part 1: Guidance on selection of tests. - International standard ISO 10993-5:2009 Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity - International standard EN/ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and delayed-type hypersensitivity - The International Standard IEC 60601-1-11: 2010 collateral standard: requirement for medical electrical equipment and medical electrical system used in the home healthcare environment. Discussion: The Compliance to applicable voluntary standards as above mentioned indicates that the new device in this submission used the same standards as that of predicate device. Therefore; we consider that the compliance of standards included in our submission is adequate for the determination of substantial equivalence. - 9. DiscussionofClinicalTestValidationActivitiesPerformedtoDeterminetheEffectivenessof Deviceare as the followings: No particular Clinical Test was conducted for Everyway OTC EMS, Model EV-805. {7}------------------------------------------------ 3FI., No. 5, Lane 155, Sec. 3,Beishen Rd., Shenkeng Dist., New Taipei City, Taiwan. ### 10. Summary for the technology comparison. Basically the Everyway OTC EMS, Model EV-805 has the similar technological characteristics with the predicate device in the product design, material, energy source type, main program mode and the main output waveform...etc. There exists some difference in the detailed output parameters (mainly in the output intensity and electrode sizes). Through the detailed calculation comparison of stimulation output energy for each operation mode(in particular the output current density and power density), we found the output level in each operation mode for our OTC EMS, Model EV-805 and predicate device are very close and within the acceptable range. So we believe the difference in detailed output parameters does not affect the determination of substantial equivalence. ### 11. Conclusions The Everyway OTC EMS, Model EV-805 has the same intended use and the similar technological characteristics as the cleared devices. Moreover, verification and validation tests contained in this submission demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared device. In the other words, those engineering difference do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device.