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 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.

AI/ML Overview

This regulatory submission for the Balego™ TENS Digital Edition with Accessories for Pain Relief (OTC) (K181207) does not contain a study that proves the device meets specific acceptance criteria in terms of performance metrics. Instead, the submission relies on demonstrating substantial equivalence to a previously cleared predicate device (EV-804 OTC Pain Relief TENS, K172919). This means that the acceptance criteria are implicitly met by virtue of being essentially the same as the predicate device, which presumably met its own acceptance criteria during its clearance.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly define acceptance criteria as performance thresholds for this specific device in comparison to a clinical outcome. Instead, the acceptance criteria are met by demonstrating the device's technical specifications and intended use are identical or very similar to the predicate device.

Acceptance Criteria (Implied)	Reported Device Performance (Balego TENS)
Premarket Clearance Standard: Substantial Equivalence to Predicate Device (K172919)	The Balego™ TENS Digital Edition is identical to the predicate device (EV-804) regarding product design, material, energy source type, indications for use, and all other technological features, except for the tradename.
Output Characteristics: Net charge, Max. phase charge, Max. current Density, Max. Average current, Max. Power Density, Burst Mode	Matches Predicate Device: Net charge = 0, Max. phase charge = 20.8 µC, Max. current Density = 0.0998 mA/cm², Max. Average current (500Ω) = 80 mA, Max. Average current (2KΩ) = 40 mA, Max. Average current (10KΩ) = 10 mA, Max. Power Density = 0.00399 Watts/cm², Burst Mode = Yes.
Output Specifications: Waveform, Shape, Max Output Voltage/Current, Duration of primary phase, Pulse Duration, Frequency, etc.	Matches Predicate Device: Waveform = Biphasic asymmetric, Shape = Rectangular, Max. Output Voltage/Current, Pulse Duration, Frequency, Power Source, Leakage Current, Number of Output Modes/Channels, Control features, Timer Range, Compliance with Voluntary Standards, Physical Dimensions, Burst parameters.
Intended Use: Temporary relief of pain associated with sore and aching muscles in low back, upper and lower extremities	Matches Predicate Device: "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."
Safety and Performance: Demonstrated through non-clinical data (electrical safety, EMC, biocompatibility, etc. – not detailed in this excerpt but required for medical devices)	Non-clinical tests were deemed sufficient by demonstrating identity to the predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not applicable in this context. The submission relies on technical comparison to a predicate device rather than a new clinical test set.
Data Provenance: Not applicable for a traditional test set. The data presented focuses on the technical specifications and comparison to a predicate device. The manufacturing establishment is in Taiwan.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable as no clinical test set requiring expert ground truth establishment was conducted.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable as no clinical test set requiring adjudication was conducted.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done. This device is a TENS unit for pain relief, not an AI-powered diagnostic tool engaging human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No standalone algorithm performance study was done. This device is a physical TENS unit.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable for a "ground truth" in the typical sense of a diagnostic or prognostic device. The "ground truth" for this submission is the established performance and safety profile of the predicate device based on its own prior clearance.

8. The sample size for the training set

Not applicable. There is no training set for an AI algorithm mentioned.

9. How the ground truth for the training set was established

Not applicable. There is no training set for an AI algorithm mentioned.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study that "proves" the device meets acceptance criteria is a technical and regulatory comparison study against a legally marketed predicate device (EV-804 OTC Pain Relief TENS, K172919). The core argument is that, because the Balego™ TENS Digital Edition is identical in all material respects (intended use, technological characteristics, manufacturing, and general labeling) to its predicate device, it is therefore substantially equivalent and inherently meets the same safety and effectiveness standards that the predicate device met for its clearance.

The report states: "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." This explicitly indicates that a new dedicated study to establish functional performance or clinical efficacy was not undertaken for K181207.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	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.Shenkeng Dist., New Taipei City, 22203, Taiwan
Registration Number:	9616877
Operations ManufacturerOwner/Operator:	Everyway Medical Instrument CO., LTD.
Contact Person:	Robert Tu
Phone:	886-2-2662-0038
Fax No:	886-2-2664-5566
e-mail:	robert@everyway-medical.com

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

3. Name of the Subject Device and Classification Information:

Tradename/DeviceName	Balego™ TENS Digital Edition with Accessories for PainRelief (OTC)
RegulationNumber	21 CFR 882.5890
Classification Name	Transcutaneous electrical nerve stimulator for pain relief.
Regulatory Class	Class II
Product Code	NUH

1. 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:

6. Indications for Use:

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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(5x5 cm)/K083302	Self Adhesive Electrode(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. Averagecurrent(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(volts) (+/- 20 %)		40V @500Ω80V @2KΩ100V @10KΩ	40V @500Ω80V @2KΩ100V @10KΩ
Maximum Output Current(mA) (+/- 20 %)		80mA @500Ω40mA @2KΩ10mA@10KΩ	80mA @500Ω40mA @2KΩ10mA@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
multiphasicwaveformsonly:	Yes	Yes	Yes
	Not applicable	Not applicable	Not applicable

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		Predicate Device	New Device
Power Source(s)		9V x 1(6F22Size)	9V x 1(6F22Size)
		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 whendevice is on but no pulses are being applied(uA)		Not applicable	Not applicable
Number of Output Modes		8	8
Number of Output	Synchronous	Synchronous	Synchronous
Channels:	OutputCoil	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 andContinuous	15, 30,60 andContinuous
		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 eachprogram	Same for eachprogram

Method of achieving zero net charge for netcharge/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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1. 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.

Regulation Number and Section

§ 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).