Everyway OTC EMS, Model EV-805

• K Number: K162744
• Device Name: Everyway OTC EMS, Model EV-805
• Manufacturer: EVERYWAY MEDICAL INSTRUMENT CO., LTD.
• Date Cleared: 2017-08-03 ( 307 days)
• Product Code: NGX
• Regulation Number: 890.5850

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.

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.

Predicate Devices

K102926

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a basic electrical muscle stimulator with manual controls and no mention of adaptive algorithms, data processing, or learning capabilities.

Therapeutic

No
The device is described as improving or facilitating muscle performance, which aligns with fitness or training rather than treating a medical condition or disease.

Diagnostic

No

The device description and intended use state that the Everyway OTC EMS is a muscle stimulator intended to improve or facilitate muscle performance through training and stimulation, not for diagnosing any condition.

SaMD (Software as a Medical Device)

No

The device description explicitly details physical hardware components such as an outer housing, output contact probes, and a battery, indicating it is a physical device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use/Indications for Use: The intended use is to "stimulate healthy muscles in order to improve or facilitate muscle performance." This is a physical therapy/rehabilitation type of use, not a diagnostic one.
• Device Description: The device is a "dual channel powered muscle stimulator" that applies electrical current to electrodes on the skin. This is consistent with an external physical therapy device, not a device that analyzes biological samples.
• Lack of Diagnostic Activity: There is no mention of the device analyzing blood, urine, tissue, or any other biological sample to diagnose a condition or provide information about a patient's health status.
• Over-the-Counter (OTC) Use: While some IVDs can be OTC, the nature of this device's function (muscle stimulation) is not typical of an IVD.
• Predicate Device: The predicate device (K102926: Gemore Muscle Conditioner/Model GM320PE) is also a muscle stimulator, further supporting that this device falls under the category of physical therapy/rehabilitation devices, not IVDs.

In summary, the Everyway OTC EMS is a muscle stimulator intended for improving muscle performance through electrical stimulation, which is not the function of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes (comma separated list FDA assigned to the subject device)

NGX

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.

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

No particular Clinical Test was conducted for Everyway OTC EMS, Model EV-805.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K102926

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).

Summary

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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 [phone] or [phone] 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 [phone] or [phone] 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

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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:[phone] FaxNo.:886-2-2664-5566 e-mail : [e-mail]
• 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
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.	The Gemore muscle conditioner,
model GM310PE/GM320PE/
GM330PE/GM340PE/GM350PE are
intended to stimulate healthy muscles
in order to improve or facilitate muscle
performance.
The Gemore muscle conditioner,
model GM310PE/GM320PE/
GM330PE/GM340PE/GM350PE are
not intended to be used in conjunction
with therapy or treatment of medical
diseases or medical conditions of any
kind. None of the Gemore muscle
conditioned training programs are
designed for injured or ailing muscle
and it's use on such muscle in
contraindicated. The Gemore muscle
conditioner, model
GM310PE/GM320PE/
GM330PE/GM340PE/GM350PE
electrically impulse triggering actions
potentials on motoneurones of motor
nerves (excitations). The excitations
motoneurones are transmitted to the
muscle fibers via the motor endplate
where they generate mechanical
muscle fiber response that correspond
to muscle work. Depending on the
parameters of the electrical impulses
(pulse frequency, duration of
contraction, duration of rest, total
session duration), different type of
muscle work can be imposed on the
stimulated muscles. The various types
of muscle work that Gemore muscle
conditioner can impose on the
stimulated muscles are able to
improve or facilitate muscle
performance. The Gemore muscle
conditioner, model
GM310PE/GM320PE/
GM330PE/GM340PE/GM350PE may
therefore be considered a technique of
muscle training.	SE*
Waveform (e.g., pulsed monophasic),	Biphasic	Biphasic	Identical
Shape (e.g., rectangular, spike,
rectified sinusoidal)	Rectangular	Rectangular	Identical
Maximum Output Voltage (volts)
(+/-20%)	7.66V @500Ω
8.2V @2KΩ
8.2V @10KΩ	7.5V @500Ω
18.0V @2KΩ
23V @10KΩ	SE*
Maximum Output Current (mA)
(+/-20%)	15.3mA @500Ω
4.1mA @2KΩ
0.82mA @10KΩ	15.0mA @500Ω
9.0mA @2KΩ
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
waveforms only:	Symmetrical
phases?	Yes	Yes	Identical
Maximum Charge(Microcoulombs
per pulse) (if zero, state method of
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
(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.

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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.