Balego TENS Digital Edition with Accessories for Pain Relief (OTC)

K181207 · Everyway Medical Instruments Co., Ldt. · NUH · Jun 6, 2018 · Neurology

Device Facts

• Record ID: K181207
• Device Name: Balego TENS Digital Edition with Accessories for Pain Relief (OTC)
• Applicant: Everyway Medical Instruments Co., Ldt.
• Product Code: NUH · Neurology
• Decision Date: Jun 6, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Balego™ TENS Digital Edition with Accessories for Pain Relief (OTC) 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.

Device Story

Dual-channel transcutaneous electrical nerve stimulator (TENS); applies electrical current to skin via electrodes for pain relief. Device consists of stimulus generator and electrodes. User selects pre-programmed modes with fixed pulse width, rate, and frequency; intensity is manually adjustable. Used by patients in home or non-clinical settings for temporary muscle pain relief. Output is biphasic asymmetric rectangular waveform. Device features automatic shut-off and no-load trip. Healthcare provider/patient uses output to manage pain symptoms; device provides non-pharmacological pain relief.

Clinical Evidence

No clinical data; bench testing only. Substantial equivalence established via descriptive comparison of technological characteristics and intended use.

Technological Characteristics

Dual-channel TENS; 9V battery powered; ABS housing. Biphasic asymmetric rectangular waveform. Max output: 80mA @ 500Ω. Fixed pulse width/rate/frequency per mode; adjustable intensity. Type BF applied part. Connectivity: None. Sterilization: Not specified. Software: Microprocessor-controlled.

Indications for Use

Indicated for temporary relief of pain associated with sore and aching muscles in the low back, arms, and legs due to exercise or normal household/work activities. For OTC use.

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

• EV-804 OTC Pain Relief TENS (K172919)

Reference Devices

• Everyway Electrode, Wire Series/ model no. KF5050 (K083302)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo.

June 6, 2018 Everyway Medical Instruments CO., LDT. % Aaron Hage Associate Attorney DuVal & Associates 825 Nicollet Mall, Suite 1820 Minneapolis, Minnesota 55402

Re: K181207

Trade/Device Name: Balego TENS Digital Edition with Accessories for Pain Relief (OTC) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH Dated: May 4, 2018 Received: May 7, 2018

Dear Aaron Hage:

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 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);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

William J. Heetderks -S 2018.06.06 16:37:48 -04'00'

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

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# Indications for Use

510(k) Number (if known) K181207

#### Device Name

Balego™ TENS Digital Edition with Accessories for Pain Relief (OTC)

Indications for Use (Describe)

The Balego™ TENS Digital Edition with Accessories for Pain Relief (OTC) 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) | |
|-----------------------------------------------------------------------|---------------------------------------------------------------------------------|
| <input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/3/Picture/0 description: The image shows the word "EVERYWAY" in a teal color, sandwiched between horizontal teal lines. There are three lines above the word and three lines below the word. The lines and the word are all the same color.

EVERYWAY MEDICAL INSTRUMENTS CO., LTD. 3 FL., NO. 5, Lane 155, Section 3, Beishen Rd. Shenkeng Dist., New Taipei City, 22203, Taiwan

# 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being prepared in accordance with the requirements of 21 CFR 807.92.

The assigned 510(k) number is: K181207.

- 1. Submitter's Identifications:

| Establishment: | Everyway Medical Instrument CO., LTD. |
|--------------------------------------------|--------------------------------------------------------------------------------------------------|
| Address: | 3 FL., NO. 5, Lane 155, Section 3, Beishen Rd.<br>Shenkeng Dist., New Taipei City, 22203, Taiwan |
| Registration Number: | 9616877 |
| Operations Manufacturer<br>Owner/Operator: | Everyway Medical Instrument CO., LTD. |
| Contact Person: | Robert Tu |
| Phone: | 886-2-2662-0038 |
| Fax No: | 886-2-2664-5566 |
| e-mail: | [e-mail] |

### 2. Date 510(k) Summary Prepared: April 25, 2018

### 3. Name of the Subject Device and Classification Information:

| Tradename/Device<br>Name | Balego™ TENS Digital Edition with Accessories for Pain<br>Relief (OTC) |
|--------------------------|------------------------------------------------------------------------|
| Regulation<br>Number | 21 CFR 882.5890 |
| Classification Name | Transcutaneous electrical nerve stimulator for pain relief. |
| Regulatory Class | Class II |
| Product Code | NUH |

- 4. Information of the 510(k) Cleared Device (Predicate Device):

| Tradename/Device | EV-804 OTC Pain Relief TENS |
|---------------------|-------------------------------------------------------------|
| Name | |
| 510(k) Number | K172919 |
| Regulation Number | 21 CFR 882.5890 |
| Classification Name | Transcutaneous electrical nerve stimulator for pain relief. |
| Regulatory Class | Class II |
| Product Code | NUH |

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### 5. Device Description:

The Balego™ TENS Digital Edition with Accessories for Pain Relief (OTC) 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 are fixed for every operation mode, only the intensity is adjustable within specified limit. The Balego™ TENS Digital Edition 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 Balego™ TENS Digital Edition are pre-program modes with fixed pulse width, pulse rate, frequency. The amplitude for each program are adjustable. The subject and predicate devices both use Everyway Electrode, Wire Series/ model no. KF5050, size 50x50mm, wire type as a standard accessory. The Electrode was cleared under K083302.

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. Indications for Use:

The Balego™ TENS Digital Edition with Accessories for Pain Relief (OTC) 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.

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# 7. Comparison to the 510(k) Cleared Device (Predicate Device):

| Features | Predicate Model | Proposed Model |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Model | EV-804 | BAL-820 |
| 510(K) No. | K172919 | K18XXXX |
| Prescription or OTC | OTC | OTC |
| Indication for use | The OTC Pain Relief TENS, model EV-804, 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. | The Balego™ TENS Digital Edition, model BAL-820, 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. |
| FDA product code | NUH | NUH |
| Accessory | Self Adhesive Electrode<br>(5x5 cm)/K083302 | Self Adhesive Electrode<br>(5x5 cm)/K083302 |

# Table S-1. Overview of the predicate and proposed device model

### Table S-2. Comparison of significant output characteristics.

| Comparison feature | Predicate Model | New Model |
|-----------------------------------|--------------------|--------------------|
| | EV-804 | Balego TENS |
| Net charge | 0 | 0 |
| Max. phase charge | 20.8 uc | 20.8 uc |
| Max. current Density | 0.0998 mA/cm2 | 0.0998 mA/cm2 |
| Max. Average<br>current<br>(RMSA) | 500Ω | 80 mA |
| | 2KΩ | 40 mA |
| | 10KΩ | 10 mA |
| Max. Power Density | 0.00399 Watts/ cm2 | 0.00399 Watts/ cm2 |
| Burst Mode | Yes | Yes |

# Table S-3. Comparison of output specifications.

| | | Predicate Device | New Device |
|--------------------------------------------------------|----------------|------------------------------------------|------------------------------------------|
| Mode or Program Name | | EV-804 | Balego TENS |
| 510(K) Number | | K172919 | K18XXXX |
| Waveform (e.g., pulsed monophasic, biphasic) | | Biphasic asymmetric | Biphasic asymmetric |
| Shape (e.g., rectangular, spike, rectified sinusoidal) | | Rectangular | Rectangular |
| Maximum Output Voltage<br>(volts) (+/- 20 %) | | 40V @500Ω<br>80V @2KΩ<br>100V @10KΩ | 40V @500Ω<br>80V @2KΩ<br>100V @10KΩ |
| Maximum Output Current<br>(mA) (+/- 20 %) | | 80mA @500Ω<br>40mA @2KΩ<br>10mA<br>@10KΩ | 80mA @500Ω<br>40mA @2KΩ<br>10mA<br>@10KΩ |
| Duration of primary phase (usec) | | 260 max | 260 max |
| Pulse Duration (usec) | | 8333 max | 8333 max |
| Frequency (Hz) [or Rate (pps)] | | 120 max | 120 max |
| For | | | |
| multiphasic<br>waveforms<br>only: | Yes | Yes | Yes |
| | Not applicable | Not applicable | Not applicable |

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| | | Predicate Device | New Device |
|----------------------------------------------------------------------------------------------------|-------------------------------------------|--------------------------------------|-----------------------------|
| Power Source(s) | | 9V x 1<br>(6F22<br>Size) | 9V x 1<br>(6F22<br>Size) |
| | | Type BF | Type BF |
| - Method of Line current Isolation | | --- | --- |
| - Patient Leakage Current | | --- | --- |
| - Normal condition (uA) | | Under 0.1 | Under 0.1 |
| - single Fault condition (uA) | | Under 0.5 | Under 0.5 |
| Average DC current through electrodes when<br>device is on but no pulses are being applied<br>(uA) | | Not applicable | Not applicable |
| Number of Output Modes | | 8 | 8 |
| Number of Output | Synchronous | Synchronous | Synchronous |
| Channels: | Output<br>Coil | Transformer | Transformer |
| Regulated Current or Regulated Voltage? | | Current | Current |
| | Software/Firmware/Microprocessor control? | Yes | Yes |
| Automatic Overload Trip? | | No | No |
| Automatic No-Load Trip? | | Yes | Yes |
| Automatic Shut Off? | | Yes | Yes |
| User Override control? | | No | No |
| | Yes | Yes | Yes |
| Indicator Display: | Yes | Yes | Yes |
| | Yes | Yes | Yes |
| Timer Range (Minutes) | | 15, 30,60 and<br>Continuous | 15, 30,60 and<br>Continuous |
| | | Compliance with Voluntary Standards? | |
| Compliance with 21 CFR 898? | | Yes | Yes |
| Weight (g) including battery | | 155 | 155 |
| Dimensions (mm.) [W x H x D] | | 101×68×21.5 | 101×68×21.5 |
| Housing Materials and construction | | ABS | ABS |
| Pulse per burst | | 6 | 6 |
| Burst per second | | 2 | 2 |
| Bust duration | | 260us | 260us |
| Duty Cycle | | Same for each<br>program | Same for each<br>program |
| | | | |
| Method of achieving zero net charge for net<br>charge/pulse | | wave for each pulse | wave for each pulse |

### 8. Non-Clinical Tests Performed to Determine the Safety and Performance of the Device:

Non-clinical performance data is not required to determine the safety and performance of the device. The subject device is identical to the predicate device with regards to intended use, technological characteristics, manufacturing, and labeling (apart from the different tradename). Therefore, descriptive information alone is sufficient to address the substantial equivalence determination.

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- 9. Clinical Test Validation Activities Performed to Determine the Effectiveness of Device:
Clinical tests were not conducted for the Balego TENS device because there were no changes to the indications for use or technological characteristics as compared to the predicate device that would warrant clinical testing.

# 10. Summary for the technology comparison.

As evidence by The Balego™ TENS device has the same technological characteristics as the predicate device regarding product design, material, and energy source type, and all other technological features.

## 11. Conclusions

The Balego TENS device is the identical device to the predicate device, apart from its tradename. The Balego TENS device has the same intended use and the same technological characteristics as the legally marketed predicate device. Therefore, the Balego TENS device is substantially equivalent to the predicate device.