TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.

HIVOX OTC Electrical Stimulator, EM49-2 -

EMS: The device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.

Device Description

HIVOX OTC Electrical Stimulator – EM49-1 and EM49-2, falls into the electro stimulation device category.

EM49-1 provides one basic function, TENS, whereas EM49-2 provides two basic functions, TENS/EMS:

Electrical stimulation of nerve tracts (TENS)
Electrical stimulation of muscle tissue (EMS)

The two models also feature two independent stimulation channels and four adhesive electrodes which FDA cleared k number is K132588. For TENS, EM49-1 and EM49-2 are designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities; for EMS, EM49-2 is designed to be used for stimulating healthy muscles in order to improve and facilitate muscle performance. For these purposes, the user can either choose from pre-set programs or specify their own to suit the user's individual needs.

The principle of electro stimulation units is based on the imitation of impulses in our bodies that are transferred to nerve and muscle fibers with electrodes via our skin. The electrodes can be applied to many parts of the body. In certain applications the user will merely notice a slight tingling or vibrating sensation. For EM49-1, the electrical impulses that are sent into the tissue influence the transmission of stimulation into nerves and nerve centers in the application area: for EM49-2, the electrical impulses that are sent into the tissue influence the transmission of stimulation into nerves, nerve centers and muscle groups in the application area.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the HIVOX OTC Electrical Stimulator (EM49-1, EM49-2):

This device is cleared through a 510(k) Special submission, meaning it's substantially equivalent to a previously cleared device. Therefore, the "acceptance criteria" and "device performance" are primarily demonstrated through non-clinical testing and comparison to the predicate device, rather than a standalone clinical study with specific performance metrics against a defined standard.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission showing substantial equivalence, specific numerical acceptance criteria (e.g., sensitivity, specificity) for clinical performance are not provided in the document. Instead, the acceptance criteria are about meeting various safety and performance standards for electrical stimulators. The device performance is demonstrated by successfully meeting these test requirements.

Acceptance Criteria Category	Reported Device Performance (as stated in the document)
Shelf Life	Meets requirements
Biocompatibility	Meets requirements
Software Validation	Meets requirements
Electromagnetic Compatibility (EMC) and Electrical Safety	Meets requirements
Function Test	Meets requirements
Usability	Meets requirements
Overall Substantial Equivalence	Demonstrated for intended use, design, technology/principles of operation, materials and performance compared to the predicate device (K171803).Differences (model, LCD type, button arrangement, cable plug, PCB layout, weight) do not raise new issues of substantial equivalence and do not affect intended use or fundamental scientific technology.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable. The "test set" here refers to the actual device being tested against engineering and bench standards, not a dataset of patients or images.
Data Provenance: Not applicable in the context of clinical data. The testing was non-clinical (bench testing, engineering verification).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not applicable. Ground truth for non-clinical engineering tests is established by industry standards, specifications, and established scientific principles, not by human expert opinion.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among multiple human readers interpreting clinical data. This document describes non-clinical testing.

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 study was done. This device is an electrical stimulator, not an AI-powered diagnostic tool. The submission states, "No clinical test data was used to support the decision of substantial equivalence."

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

Not applicable. This isn't an algorithm or AI device; it's an electrical stimulator. Its "performance" is measured by its electrical characteristics, safety, and functionality, not by diagnostic accuracy.

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

For the non-clinical tests (Shelf Life, Biocompatibility, Software Validation, EMC/Electrical Safety, Function test, Usability), the ground truth is established by:
- Industry standards and regulatory requirements: e.g., electrical safety standards, biocompatibility standards, software development lifecycle standards.
- Device design specifications: The device is tested to ensure it performs according to its engineered design.
- Predicate device characteristics: For substantial equivalence, the device's technical characteristics are compared to those of the predicate device.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or AI, so there is no training set.

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

Not applicable. As there is no training set for an AI/ML algorithm, this question is irrelevant.

Summary

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March 15, 2019

Hivox Biotek Inc. Marx Lee Regulatory Affairs 5F., No. 123, Xingde Rd. Sanchong Dist. New Taipei City, TW 24158

Re: K190347

Trade/Device Name: HIVOX OTC Electrical Stimulator Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX Dated: February 13, 2019 Received: February 14, 2019

Dear Marx Lee:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Actinclude 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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.

Pamela D. Scott -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

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Indications for Use

510(k) Number (if known) K190347

Device Name

HIVOX OTC Electrical Stimulator (EM49-1, EM49-2)

Indications for Use (Describe)

HIVOX OTC Electrical Stimulator, EM49-1 -

HIVOX OTC Electrical Stimulator, EM49-2 -

EMS: The device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.

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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HIVOX OTC Electrical Stimulator (EM49-1, EM49-2)

Section 6- 510(k) Summary

510(k) SUMMARY

6.1	Type of Submission:	Special
6.2	Date of Summary:	February 13, 2019
6.3	Submitter:	HIVOX BIOTEK INC.
	Address:	5F., No. 123, Xingde Rd., Sanchong Dist., NewTaipei City 24158, Taiwan, R.O.C.
	Phone:	+886-2-8511-2668
	Fax:	+886-2-8511-2669
	Contact:	Marx Lee
		(marx.lee@hivox-biotek.com)

6.4 Identification of the Device:

Proprietary/Trade name:	HIVOX OTC Electrical Stimulator
Model Number:	EM49-1, EM49-2
Classification Product Code:	NUH
Subsequent Product Code:	NGX
Regulation Number:	1) 882.58902) 890.5850
Regulation Description:	1) Transcutaneous electrical nervestimulator for pain relief2) Powered muscle stimulator
Review Panel:	1) Neurology2) Physical Medicine
Device Class:	II

6.5 Identification of the Predicate Device:

Predicate Device Name :	HIVOX OTC Electrical Stimulator
Model Number:	SEM44, SEM44-1
Manufacturer:	HIVOX BIOTEK INC.

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HIVOX OTC Electrical Stimulator (EM49-1, EM49-2)

Classification Product Code:	NUH
Subsequent Product Code:	NGX
Regulation number:	1) 882.5890
	2) 890.5850
Device Class:	II
510(k) Number:	K171803

Intended Use/Indications for Use of the Device 6.6

HIVOX OTC Electrical Stimulator, EM49-1 -

HIVOX OTC Electrical Stimulator, EM49-2 -

EMS: The device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.

6.7 De vice Descrintion

HIVOX OTC Electrical Stimulator – EM49-1 and EM49-2, falls into the electro stimulation device category.

EM49-1 provides one basic function, TENS, whereas EM49-2 provides two basic functions, TENS/EMS:

Electrical stimulation of nerve tracts (TENS)
Electrical stimulation of muscle tissue (EMS)

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6.8 Non-clinical Testing

A series of safety and performance tests were conducted on the subject device, HIVOX OTC Electrical Stimulator (EM49-1, EM49-2).

. Shelf Life
Biocompatibilit y .
Software Validation
. Electromagnetic compatibility and electrical safety
Function test
. Usability

All the test results demonstrate HIVOX OTC Electrical Stimulator (EM49-1, EM49-2) meets the requirements of its pre-defined acceptance criteria and intended use, and is substantially equivalent to the predicate device.

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Section 6- 510(k) Summary

HIVOX OTC Electrical Stimulator (EM49-1, EM49-2)

6.9 Clinical Testing

No clinical test data was used to support the decision of substantial equivalence.

Comparison of Differences and Substantial Equivalence Determination 6.10

The HIVOX OTC Electrical Stimulator (EM49-1, EM49-2) submitted in this 510(k) file is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the cleared HIVOX OTC Electrical Stimulator (SEM44, SEM44-1) (K171803). Differences between the devices cited in the following do not raise any new issue of substantial equivalence.

Subject device	Predicate device	Substantial equivalence determination
Model:EM49-1/EM49-2	Model:SEM44/SEM44-1	Different in product model.However, it does not affect the intended use or alter thefundamental scientific technology of subject device.
Negativedisplay type LCD	Positivedisplay type LCD	Changed for the sake of product segmentation.However, it does not affect the intended use or alter thefundamental scientific technology of subject device.
Arrangement of buttons		Changed for the sake of product segmentation.However, it does not affect the intended use or alter thefundamental scientific technology of subject device.
Type of connection cable plug		Changed for the sake of product segmentation.However, it does not affect the intended use or alter thefundamental scientific technology of subject device.
PCB layout		Changed due to the use of different type of LCD andarrangement of buttons.However, it does not affect the intended use or alter thefundamental scientific technology of subject device.
Weight		Difference because of different design of product appearance.However, it does not affect the intended use or alter thefundamental scientific technology of subject device.

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HIVOX OTC Electrical Stimulator (EM49-1, EM49-2)

6.11 Discussion

The HIVOX OTC Electrical Stimulator (EM49-1, EM49-2) has been compared with "HIVOX OTC Electrical Stimulator (SEM44, SEM44-1)". The subject device has same intended use, principle of operation and technological characteristics as the predicate device. We have completed the design control process and the validation tests to confirm the safety and performance of subject device. Although there are some specifications that are different between two devices, the test results complied with the test requests, and this demonstrates that the differences between these parameters would not impact the safety and effectiveness of the subject device. Therefore, the difference between the subject device and the predicate device did not raise any problem of substantial equivalence. The subject device is substantially equivalent to the predicate device in intended use, safety and performance claims.

6.12 Conclusion

After analyzing non-clinical laboratory studies and related testing data, it can be concluded that the HIVOX OTC Electrical Stimulator (EM49-1, EM49-2) is substantially equivalent to the predicate device.

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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).