(136 days)
No
The device description explicitly states that the output and waveform characteristics are fixed, and the stimulation modes are pre-programmed with fixed parameters. There is no mention of adaptive learning, data analysis for personalized treatment, or any other characteristic typically associated with AI/ML in medical devices.
Yes
The device is intended for the temporary relief of pain associated with sore and aching muscles, which is a therapeutic purpose.
No
The device is a TENS unit, which is used for pain relief by applying electrical stimulation. Its intended use is for "temporary relief of pain associated with sore and aching muscles," which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it consists of a "stimulus generator" and "electrode," which are hardware components. It is a physical TENS device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Everyway EV-820 OTC Pain Relief TENS is a Transcutaneous Electrical Nerve Stimulator (TENS) device. It works by applying electrical current to the skin to provide temporary pain relief. It does not analyze any samples from the body.
- Intended Use: The intended use is for temporary relief of pain in specific body areas. This is a therapeutic function, not a diagnostic one.
- Device Description: The description details the electrical stimulation mechanism and components, not any methods for analyzing biological samples.
Therefore, based on the provided information, the Everyway EV-820 OTC Pain Relief TENS is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Everyway EV-820 OTC Pain Relief TENS is intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.
Product codes
NUH
Device Description
The Everyway EV-820 OTC Pain Relief TENS is a dual channel transcutaneous electrical nerve stimulator used for pain relief by applying an electrical current to electrodes, which are attached on the user's skin. The output and waveform characteristic is fixed for every operation mode, only the intensity is adjustable within specified limit.
The Everyway EV-820 OTC Pain Relief TENS consists mainly of two parts: the stimulus generator, electrode. The stimulus generator generates the output current specified as the input of controller. The output port transmits the output current to the electrode, which is attached to the user's skin so as to transmit this stimulus current for pain relief.
The stimulation modes for Everyway EV-820 OTC Pain Relief TENS is pre-program modes with fixed pulse width, pulse rate, frequency. The timer and amplitude for each program are adjustable. This operation way is considered the simple design change from the pre-program modes of comparison clear model, existing 510(k) cleared devices, Low Back Pain Relief System/ Model EV-820(K110716). Every operation mode of Everyway EV-820 OTC Pain Relief TENS Syste has its individual stimulation operation cycle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
low back as well as upper and lower extremities (arm and/or leg)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
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 EV-820 OTC Pain Relief TENS.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K110716, K062675, K082065, K083302
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three heads facing to the right. The eagle is black and is positioned to the right of the text. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the left side of the seal.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 16, 2015
Everyway Medical Instruments Co., Ltd. Robert Tu President And Operator Owner 3 Fl., No. 5, Lane 155, Section 3, Peishen Rd., Shenkeng Hsiang, Taipei Hsien, 222 TW
Re: K151479
Trade/Device Name: EverywayEV-820 OTC Pain Relief TENS Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH Dated: September 12, 2015 Received: September 15, 2015
Dear Mr. Tu:
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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael J. Hoffmann -S
for 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
Indications for Use
510(k) Number (if known) K151479
Device Name Everyway EV-820 OTC Pain Relief TENS
Indications for Use (Describe)
The Everyway EV-820 OTC Pain Relief TENS is intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3Fl., No. 5, Lane 155, Sec. 3,Peishen Rd, Shen Keng Hsiang, Taipei Hsien, 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 October 01, 2015.
The assigned 510(k) number is: K151479
-
- Submitter's Identifications: Establishment:EVERYWAY MEDICAL INSTRUMENT CO., LTD. Address: 3Fl., No. 5, Lane 155, Sec. 3, Peishen Rd., Shenkeng Hsiang, Taipei Hsien 222, Taiwan Registration Number: 9616877 Operations: Manufacturer
Owner/Operator:EVERYWAY MEDICAL INSTRUMENT CO., LTD. Address : 3Fl., No. 5, Lane 155, Sec. 3, Peishen Rd., Shenkeng Hsiang, Taipei Hsien 222, Taiwan Contact Person: Robert Tu Phone : 886-2-2662-0038 Fax No: 886-2-2664-5566 e-mail : tu922@ms35.hinet.net
- Submitter's Identifications: Establishment:EVERYWAY MEDICAL INSTRUMENT CO., LTD. Address: 3Fl., No. 5, Lane 155, Sec. 3, Peishen Rd., Shenkeng Hsiang, Taipei Hsien 222, Taiwan Registration Number: 9616877 Operations: Manufacturer
-
- Name of the Device: Everyway EV-820 OTC Pain Relief TENS.
- Classification Information: Trade/Device Name: Everyway EV-820 OTC Pain Relief TENS. Requlation Number: 21 CFR 882,5890 Classification Name: Stimulator, Nerve, Transcutaneous For Pain Relief. Requlatory Class: II Product Code: NUH
5. Device Description:
The Everyway EV-820 OTC Pain Relief TENS is a dual channel transcutaneous electrical nerve stimulator used for pain relief by applying an electrical current to electrodes, which are attached on the user's skin. The output and waveform characteristic is fixed for every operation mode, only the intensity is adjustable within specified limit.
The Everyway EV-820 OTC Pain Relief TENS consists mainly of two parts: the stimulus generator, electrode. The stimulus generator generates the output current specified as the input of controller. The output port transmits the output current to the electrode, which is attached to the user's skin so as to transmit this stimulus current for pain relief.
The stimulation modes for Everyway EV-820 OTC Pain Relief TENS is pre-program modes with fixed pulse width, pulse rate, frequency. The timer and amplitude for each program are adjustable. This operation way is considered the simple design change from the pre-program modes of comparison clear model, existing 510(k) cleared devices, Low Back Pain Relief System/ Model EV-820(K110716). Every operation mode of Everyway EV-820 OTC Pain Relief TENS Syste has its individual stimulation operation cycle.
4
3Fl., No. 5, Lane 155, Sec. 3,Peishen Rd, Shen Keng Hsiang, Taipei Hsien, Taiwan,
For the device included in this submission, we use the following of our 510(K) legally marketed electrodes:K062675, "Everyway Lifecare Electrode", Wire Series/ model no. TFK5050, size 50x50mm, wire type as standard accessory.
With the combination of the main device parts, the device can be placed on the treatment locations as recommended in the user manual for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.
6. Intended Use:
The Everyway EV-820 OTC Pain Relief TENS is intended for temporary relief of pain associated with sore and aching muscles in the low back and/or upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.
7. Comparison to the 510(k) Cleared Device (Predicate Device):
| The following features are completely identical among the predicate device and our device | |||
|---|---|---|---|
| Features | 510(K) Cleared Models | New Model | |
| Model | WL-2406 | WL-2407 | EV-820 |
| 510(K) No. | K133723 | K091757 | Unknown |
| Prescription or OTC | OTC | OTC | OTC |
| Indication for use | temporary relief of pain | ||
| associated with sore and | |||
| aching muscles in the low | |||
| back as well as upper and | |||
| lower extremities (arm and/ | |||
| or leg) due to strain from | |||
| exercise or normal House- | |||
| hold and work activities | temporary relief of pain | ||
| associated with sore and | |||
| aching muscles in the upper | |||
| And lower extremities (arm | |||
| and/or leg) due to strain from | |||
| exercise or normal House- | |||
| hold and work activities | temporary relief of pain | ||
| associated with sore and | |||
| aching muscles in the low | |||
| back as well as upper and | |||
| lower extremities (arm and/ | |||
| or leg) due to strain from | |||
| exercise or normal House- | |||
| hold and work activities | |||
| FDA product code | NUH | NUH | NUH |
| Electrode Used | Self Adhesive Electrode | ||
| (13x7 cm)/K082065 | Belt Electrode and/or | ||
| Self Adhesive Electrode | |||
| (5 x 5 cm)/K082065 | Self Adhesive Electrode | ||
| (5x5 cm)/K083302 |
8. Significant output characteristics comparison table:
| Comparison feature | 510(K) Cleared Model | New Model |
|---|---|---|
| WL-2406(K133723) | ||
| WL-2407(K091757) | EV-820 | |
| Net charge | 0 | |
| 0 | 0 | |
| Max. phase charge | 13 uc | |
| 20.8 uc | 20.8 uc | |
| Max. current Density | 0.04875 mA/cm² | |
| 0.04992 mA/cm² | 0.0998 mA/cm² | |
| Max. Average current (RMSA) | 500 Ω: 50 mA | |
| 2K Ω: 22.5 mA | ||
| 10K Ω: 7.5 mA | 80 mA | |
| 30 mA | ||
| 10 mA | ||
| Max. Power Density | 0.001219 Watts/ cm² | |
| 0.00200 Watts/ cm² | 0.00399 Watts/ cm² | |
| Burst Mode | Yes | |
| Yes | Yes |
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3Fl., No. 5, Lane 155, Sec. 3,Peishen Rd, Shen Keng Hsiang, Taipei Hsien, Taiwan,
Comparison of Unit Characteristics & Output Specification
| Predicate Device | New Device | |||
|---|---|---|---|---|
| Mode or Program Name | WL-2406 | WL-2407 | EV-820 | |
| 510(K) Number | K133723 | K091757 | Unknown | |
| Waveform (e.g., pulsed monophasic, biphasic) | Biphasic | Biphasic | Biphasic asymmetric | |
| Shape (e.g., rectangular, spike, rectified sinusoidal) | Rectangular | Rectangular | Rectangular | |
| Maximum Output Voltage (volts) | ||||
| (+/-_20 %) | 25V @500Ω | |||
| 45V @2KΩ | ||||
| 75V @10KΩ | 40V @500Ω | |||
| 60V @2KΩ | ||||
| 100V @10KΩ | 40V @500Ω | |||
| 80V @2KΩ | ||||
| 100V @10KΩ | ||||
| Maximum Output Current (mA) | ||||
| (+/-_20 %) | 50mA @500Ω | |||
| 22.5mA @2KΩ | ||||
| 7.5mA @10KΩ | 80mA @500Ω | |||
| 30mA @2KΩ | ||||
| 10mA @10KΩ | 80mA @500Ω | |||
| 40mA @2KΩ | ||||
| 10mA @10KΩ | ||||
| Duration of primary phase (usec) | 260 max | 260 max | 260 max | |
| Pulse Duration (usec) | 8333 max | 16666 max | 8333 max | |
| Frequency (Hz) [or Rate (pps)] | 120 max | 60 max | 120 max | |
| For | ||||
| multiphasic | ||||
| waveforms | ||||
| only: | Yes | Yes | Yes | Yes |
| Not applicable | Not applicable | Not applicable | Not applicable | |
| Power Source(s) | 1.5Vx2 | |||
| (AAA Size) | 1.5Vx3 | |||
| (AAA Size) | 9V x 1 | |||
| (6F22 Size) | ||||
| - Method of Line current Isolation | Type BF | Type BF | Type BF | |
| - Patient Leakage Current | --- | --- | --- | |
| - Normal condition (uA) | Under 0.1 | Under 0.1 | Under 0.1 | |
| - single Fault condition (uA) | Under 0.5 | Under 0.5 | Under 0.5 | |
| Average DC current through electrodes when | ||||
| device is on but no pulses are being applied (uA) | Not applicable | Not applicable | Not applicable | |
| Number of Output Modes | 8 | 8 | 8 | |
| Number of Output Channels: | Synchronous | |||
| Output Coil | Synchronous | |||
| Output Coil | Synchronous | |||
| Transformer | ||||
| Regulated Current or Regulated Voltage? | Voltage | Voltage | Current | |
| Software/Firmware/Microprocessor control? | Yes | Yes | Yes | |
| Automatic Overload Trip? | No | No | No | |
| Automatic No-Load Trip? | Yes | Yes | Yes | |
| Automatic Shut Off? | Yes | Yes | Yes | |
| User Override control? | No | No | No | |
| Indicator Display: | Yes | Yes | Yes | |
| Yes | Yes | Yes | ||
| Timer Range (Minutes) | 10-60 | 5-60 | 15, 30,60 and Continuous | |
| Compliance with Voluntary Standards? | IEC 60601-2-10 | IEC 60601-2-10 | IEC 60601-2-10 | |
| Compliance with 21 CFR 898? | Yes | Yes | Yes | |
| Weight (g) including battery | 51.6 | 125.5 | 142 | |
| Dimensions (mm.) [W x H x D] | 68x60x17.5 | 90x50.8x12.7 | 110x62x27 | |
| Housing Materials and construction | ABS | ABS | ABS | |
| Pulse per burst | 9 | 9 | 6 | |
| Burst per second | 2 | 2 | 2 | |
| Bust duration | 260us | 260us | 260us | |
| Duty Cycle | Same for each | |||
| program | Same for each | |||
| program | Same for each | |||
| program | ||||
| Method of achieving zero net charge for net | ||||
| charge/pulse | Biphasic | |||
| symmetric | ||||
| wave for each | ||||
| pulse | Biphasic | |||
| symmetric | ||||
| wave for each | ||||
| pulse | Biphasic | |||
| asymmetric | ||||
| wave for each | ||||
| pulse |
9. 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, 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 quidance.
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.
6
3Fl., No. 5, Lane 155, Sec. 3,Peishen Rd, Shen Keng Hsiang, Taipei Hsien, Taiwan,
-
- Discussion of Clinical Test Validation Activities Performed to Determine the Effectiveness of Device are as the followings:
No particular Clinical Test was conducted for Everyway EV-820 OTC Pain Relief TENS.
- Discussion of Clinical Test Validation Activities Performed to Determine the Effectiveness of Device are as the followings:
-
- Summary for the technology comparison.
Basically the Everyway EV-820 OTC Pain Relief TENS 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 Everyway EV-820 OTC Pain Relief TENS 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.
- Summary for the technology comparison.
-
- Conclusions
The Everyway EV-820 OTC Pain Relief TENS 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.
- Conclusions
In the other words, those engineering difference do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device.