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.

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

HIVOX OTC Electrical Stimulator, SEM44-1 -

Device Description

HIVOX OTC Electrical Stimulator - SEM44 and SEM44-1, falls into the electro stimulation device category.

SEM44 provides two basic functions, TENS/EMS; SEM44-1 provides one basic function, TENS:

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, SEM44 and SEM44-1 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, SEM44 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 SEM44, 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; for SEM44-1, the electrical impulses that are sent into the tissue influence the transmission of stimulation into nerves and nerve centers in the application area.

AI/ML Overview

The provided document is a 510(k) summary for the HIVOX OTC Electrical Stimulator (Models SEM44 and SEM44-1). It does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/algorithm-driven medical device. Instead, it details a substantial equivalence determination based on non-clinical testing for an electrical stimulator.

Therefore, most of the requested information regarding acceptance criteria, study design, ground truth, and sample sizes for an AI/algorithm device is not applicable or cannot be extracted from this document.

However, I can extract the information relevant to the non-clinical testing performed and the comparison with predicate devices.

Here's a breakdown of the available information based on your request, with a note where information is not present:

Acceptance Criteria and Device Performance Study for HIVOX OTC Electrical Stimulator (SEM44, SEM44-1)

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific numerical targets for each parameter. Instead, it states that "All the test results demonstrate HIVOX OTC Electrical Stimulator (SEM44, SEM44-1) meets the requirements of its pre-defined acceptance criteria and intended uses, and is substantially equivalent to the predicate devices."

The comparison tables (pages 7-10 and 13-16) describe various technical specifications of the subject device and the predicate devices. For each difference, the document states: "Different but does not adversely impact safety and effectiveness of subject device." This implicitly indicates that the subject device's performance, despite differences, falls within an acceptable range for safety and effectiveness as determined by comparison to the predicate.

Non-Clinical Testing & Performance Summary

Test Category	Reported Device Performance	Implicit Acceptance Criteria / Comparison Basis
Shelf Life	Met requirements	Pre-defined acceptance criteria, comparable to predicate devices.
Biocompatibility	Met requirements	Pre-defined acceptance criteria, comparable to predicate devices.
Software Validation	Met requirements	Pre-defined acceptance criteria, comparable to predicate devices. (Both subject and predicates use software/firmware)
Electromagnetic compatibility (EMC) & Electrical Safety	Met requirements (Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO10993-5/10, 21 CFR 898-7)	Compliance with listed international and national standards.
Function Test	Met requirements	Pre-defined acceptance criteria, comparable to predicate devices.
Primary Output Parameters (e.g., Voltage, Current, Frequency, Pulse Duration)	Varied slightly from predicates but deemed not to adversely impact safety/effectiveness.	Within acceptable ranges for safe and effective transcutaneous electrical nerve stimulation (TENS) and electrical muscle stimulation (EMS), as demonstrated by predicate devices.
Physical Characteristics (Weight, Dimensions)	Slightly different from predicates but deemed not to adversely impact safety/effectiveness.	Within acceptable ranges for design and handling, as demonstrated by predicate devices.

2. Sample size used for the test set and the data provenance

Sample Size: Not applicable. This document describes non-clinical engineering and performance testing of a physical device, not an AI/algorithm using a test set of data.
Data Provenance: Not applicable. The tests performed are laboratory-based non-clinical tests on the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not an AI/algorithm study requiring expert-established ground truth.

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

Not applicable. This is not an AI/algorithm study involving adjudication of results.

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

Not applicable. This document is for an electrical stimulator, not an AI-assisted diagnostic or treatment device.

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

Not applicable. This refers to an AI algorithm. The device here is an electrical stimulator.

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

Not applicable. For the non-clinical tests, the "ground truth" or reference standards are the specifications and requirements defined by the relevant international and national safety and performance standards (e.g., IEC 60601 series, ISO 10993 series, 21 CFR 898-7).

8. The sample size for the training set

Not applicable. This is not an AI/algorithm device.

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

Not applicable. This is not an AI/algorithm device.

Summary of the Study that Proves the Device Meets Acceptance Criteria (Non-Clinical)

The study supporting the HIVOX OTC Electrical Stimulator (SEM44, SEM44-1)'s safety and effectiveness for its intended use is a series of non-clinical tests as detailed in section 5.8 of the 510(k) summary. These tests covered:

Shelf Life: To ensure the device maintains its performance over its intended lifespan.
Biocompatibility: To confirm that the materials used in the device are safe for contact with the human body.
Software Validation: To verify that any embedded software functions correctly and safely. (Both the subject device and predicate devices utilize software/firmware/microprocessor control, as noted in the comparison tables).
Electromagnetic compatibility and electrical safety: To ensure the device operates safely in its electromagnetic environment and meets electrical safety standards. The document explicitly lists compliance with:
- IEC 60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance)
- IEC 60601-1-2 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests)
- IEC 60601-2-10 (Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators)
- ISO 10993-5/10 (Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity, and Part 10: Tests for irritation and skin sensitization)
- Compliance with 21 CFR 898-7 (Radiation protection regulations for diagnostic X-ray systems) - Note: This standard appears to be an error in context for an electrical stimulator, as 898-7 typically pertains to X-ray systems. It's likely an oversight in the document or a misstatement.
Function test: To confirm the device operates as intended in terms of its electrical stimulation outputs (TENS and EMS modes), power delivery, and user controls.

The conclusion of these tests (Section 5.8) states: "All the test results demonstrate HIVOX OTC Electrical Stimulator (SEM44, SEM44-1) meets the requirements of its pre-defined acceptance criteria and intended uses, and is substantially equivalent to the predicate devices."

The entire submission is based on demonstrating substantial equivalence to legally marketed predicate devices (K130802 and K150386). The tables provided in the document (pages 7-10 and 13-16) meticulously compare the subject device's features and specifications against those of the predicate devices. For any differences, the rationale is provided that these "do not adversely impact safety and effectiveness of subject device," thereby supporting the claim of substantial equivalence.

No clinical test data was used to support the decision of substantial equivalence (Section 5.9).

Summary

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Image /page/0/Picture/0 description: The image contains the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size, also in blue. The logo is simple and professional, and it is easily recognizable.

November 29, 2017

Hivox Biotek Inc. Linda Lin Territory Sales 5F., No. 123, Xingde Rd. Sanchong Dist. New Taipei City, 24158 Tw

Re: K171803

Trade/Device Name: HIVOX OTC Electrical Stimulators Model SEM44 and Model SEM44-1 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX Dated: August 21, 2017 Received: August 31, 2017

Dear Linda Lin:

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

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manufacturing practice requirements as set forth in 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.

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.

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 2017.11.29 20:14:45 -05'00'

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)

Device Name

HIVOX OTC Electrical Stimulator (SEM44, SEM44-1)

Indications for Use (Describe)

HIVOX OTC Electrical Stimulator, SEM44 -

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

HIVOX OTC Electrical Stimulator, SEM44-1 -

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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Traditional 510(k), K171803/AIR Section 5 - 510(k) Summary

510(k) SUMMARY

5.1	Type of Submission:	Traditional
5.2	Date of Summary:	November 29, 2017
5.3	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:	Mr. Linda Lin(linda.lin@hivox-biotek.com)

5.4 Identification of the Device:

Proprietary/Trade name:	HIVOX OTC Electrical Stimulator
Model Number:	SEM44, SEM44-1
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

5.5 Identification of the Predicate Device:

Predicate Device Name:	OTC Electrical stimulator
Model Number:	MT9001, LT3060
Manufacturer:	Shenzhen Dongdixin Technology Co., Ltd.

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Classification Product Code:	NUH
Subsequent Product Code:	NGX
Regulation number:	882.5890
Device Class:	II
510(k) Number:	K130802
Predicate Device Name:	Tyece OTC TENS Device
Model Number:	SEM44
Manufacturer:	SAVIA Ltd.
Classification Product Code:	NUH
Regulation number:	882.5890
Device Class:	II
510(k) Number:	K150386

5.6 Intended Use/ Indications for Use of the Device

HIVOX OTC Electrical Stimulator, SEM44 -

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

HIVOX OTC Electrical Stimulator, SEM44-1 -

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5.7 Device Description

HIVOX OTC Electrical Stimulator - SEM44 and SEM44-1, falls into the electro stimulation device category.

SEM44 provides two basic functions, TENS/EMS; SEM44-1 provides one basic function, TENS:

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

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5.8 Non-clinical Testing

A series of safety and performance tests were conducted on the subject device, HIVOX OTC Electrical Stimulator (SEM44, SEM44-1).

Shelf Life
. Biocompatibility
Software Validation
Electromagnetic compatibility and electrical safety
Function test

All the test results demonstrate HIVOX OTC Electrical Stimulator (SEM44, SEM44-1) meets the requirements of its pre-defined acceptance criteria and intended uses, and is substantially equivalent to the predicate devices.

5.9 Clinical Testing

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

5.10 Substantial Equivalence Determination

The HIVOX OTC Electrical Stimulator (SEM44, SEM44-1) submitted in this 510(k) file is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the cleared OTC Electrical stimulator Models MT9001, LT3060 (K130802) and Tyece OTC TENS Device, Model SEM44 (K150386). Differences between the devices cited in this section do not raise any new issue of substantial equivalence.

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Item	Subject device	Predicate device I	Substantial equivalence determination
Proprietary Name	HIVOX OTC Electrical Stimulator	OTC Electrical stimulator	N/A
Model	SEM44SEM44-1	MT9001LT3060
510(k) No.	(to be assigned)	K130802
Intended Use	SEM44 –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.EMS: The device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.	MT9001 -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), and lower extremities (leg) due to strain from exercise or normal household work activities.EMS: The device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.LT3060 -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	Similar.Both devices utilize TENS to release pain associated with sore and aching muscles, and EMS to improve and facilitate muscle performance.

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		shoulder, waist, back, neck, upper extremities (arm), upper extremities (arm), lower extremities (leg) abdomen and bottom due to strain from exercise or normal household work activities.	and lower extremities (leg) due to strain from exercise or activities. normal household work activities.
	Type of use	OTC	OTC	Same
		Basic Unit Characteristics
Power Source		4.5V (batteries, 3x1.5V AAA)	9V batteries	Different but does not adversely impact safety and effectiveness of subject device
Method of Line Current Isolation		N/A	N/A	Same
Patient Leakage Current	Normal condition	N/A	0.61μA	This parameter is not applicable to subject device.
	Single fault condition	N/A	0.68μA
Number of Output Modes		TENS: 15EMS: 35	TENS: 1EMS: 1	Different but does not adversely impact safety and effectiveness of subject device
Number of Output Channels	Synchronous or Alternating	2 Synchronous	Alternating	Different but does not adversely impact safety and effectiveness of
		Method ofChannelIsolation		subject device
		By electrical circuit andsoftware	By electrical circuit andsoftware	Same
	Regulated Current orRegulated Voltage?	Regulated voltage	Current control	Different butdoes notadversely impactsafety andeffectiveness ofsubject device
	Software/Firmware/Microprocessor Control?	Yes	Yes	Same
	Automatic Overload Trip?	Yes	Yes	Same
	Automatic No-Load Trip?	Yes	Yes	Same
Automatic Shut Off?		Yes	Yes	Same
User Override Control?		Yes	Yes	Same
IndicatorDisplay	On/OffStatus	Yes	Yes	Same
	Low Battery	Yes	Yes	Same
	Voltage/CurrentLevel	Yes	Yes	Same
Timer Range (minutes)		5-100 minutes	1-60 minutes	Different butdoes notadversely impactsafety andeffectiveness ofsubject device
Compliance with VoluntaryStandards		IEC 60601-1,IEC 60601-1-2.	IEC 60601-1,IEC 60601-1-2.	Same

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	IEC 60601-2-10,ISO10993-5/10	IEC 60601-2-10,ISO10993-5/10
Compliance with 21 CFR898-7	Yes	Yes	Same
Weight	89 g (including belt clip,without batteries),123 g (including belt clipand batteries)	128g (including batteries)	Slightly differentbut does notimpact safety andeffectiveness ofsubject device
Dimensions [L x W x T]	132 x 63 x 29.5 mm(including belt clip)	117 x 60 x 34 mm	Slightly differentbut does notimpact safety andeffectiveness ofsubject device
Housing Materials andConstruction	ABS	ABS	Same
Output Specifications
Waveform (e.g., pulsedmonophasic, biphasic)	Biphasic	Biphasic	Same
Shape (e.g., rectangular,spike, rectified sinusoidal)	Square	Square	Same
MaximumOutput Voltage(Volts, Vpp)	@500Ω	100±10%	96±20%(48±20% (Vp))	Different but
	@2KΩ	180±10%	200±20%(100±20%(Vp))228±20%(114±20%(Vp))	does notadversely impactsafety and
	@10KΩ	250±10%	210±20%(105±20%(Vp))230±20%(115±20%(Vp))	effectiveness ofsubject device
Maximum	@500Ω	200±10%	96±20%	Different but

OutputCurrent (mA)	@2KΩ	90±10%	50±20%	57±20%	does notadversely impactsafety andeffectiveness ofsubject device
	@10KΩ	25±10%	10.5±20%	11.5±20%
Duration of primary phase		50-450μS		50-300μS	Different butdoes notadversely impactsafety andeffectiveness ofsubject device
Pulse Duration		50-450μS		50-300μS	Different butdoes notadversely impactsafety andeffectiveness ofsubject device
Frequency		1-150Hz	1-150Hz		Same
For interferential modesonly – Beat Frequency		N/A	N/A		Same
Formulti-programwaveformsonly –	SymmetricalPhases?	N/A	Yes		This parameter isnot applicable tosubject device.
	PhaseDuration	N/A	50-300μS
Net charge (micro coulombsµC) (per pulse)		0.001μC@500Ω	0μC@500Ω		Same
method of achieving zeronet charge		N/A	biphasic and leadingpolarity alternates for eachsuccessive, Pulse + andpulse – pulse channel		This parameter isnot applicable tosubject device.
Max. phase charge (mC)		0.045@500Ω	0.0288@500Ω		Different butdoes not
					adversely impactsafety andeffectiveness ofsubject device
					Different butdoes notadversely impactsafety andeffectiveness ofsubject device
Max. current Density(mA/cm², r.m.s)		0.667@500Ω		1.15@500Ω	Different butdoes notadversely impactsafety andeffectiveness ofsubject device
Max. Average current(average absolute value),mA		13.5@500Ω		4.32@500Ω	Different butdoes notadversely impactsafety andeffectiveness ofsubject device
Max. Average PowerDensity, W/cm² (usingsmallest electrodeconductive surface area)		0.0046@500Ω		0.373@500Ω	Different butdoes notadversely impactsafety andeffectiveness ofsubject device
BurstMode(i.e.pulsetrains)	(a) Pulses per burst	3	7	N/A	Different butdoes notadversely impactsafety andeffectiveness ofsubject device
	(b) Bursts persecond	2/60Hz	0.5/1/2/3/4/5Hz	N/A	Different butdoes notadversely impactsafety andeffectiveness ofsubject device
	(c) Burst duration	36ms	70ms	N/A	Different butdoes notadversely impactsafety andeffectiveness ofsubject device
	(d) Duty cycle	36ms/390ms	35ms/350ms	N/A	Different butdoes notadversely impactsafety andeffectiveness ofsubject device
ON Time (seconds)		2	N/A	1-30	Similar and doesnot impact safetyand effectivenessof subject device
OFF Time (seconds)	2	N/A	1-60	Similar and doesnot impact safetyand effectivenessof subject device
Electrode area	20.25sqcm x4 (81sqcm)	25sqcm x2 (100sqcm)	Different butdoes notadversely impactsafety andeffectiveness ofsubject device
Average DC current throughelectrodes when device is onbut no pulses are beingapplied (µA)	0	0	Same

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Item	Subject device	Predicate device II	Substantialequivalencedetermination
Proprietary Name	HIVOX OTC ElectricalStimulator	Tyece OTC TENS Device	N/A
Model	SEM44-1	SEM44	N/A
510(k) No.	(to be assigned)	K150386	N/A
Intended Use	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	The Tyece OTC TENS Device, Model SEM44 is to be used for temporary relief of pain associated with sore and aching muscles in the lower back, arms, or legs due to strain from exercise or normal household activities.	Similar.Both devices utilize TENS to release pain associated with sore and aching muscles.

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		householdnormalwork
		activities.
Type of use		OTC	OTC	Same
	Basic Unit Characteristics
Power Source		4.5V (batteries, 3x1.5V	4.5V (batteries, 3x1.5V	Same
		AAA)	AAA)
	Method of Line CurrentIsolation	N/A	N/A	Same
Patient	Normal condition	N/A	N/A	Same
LeakageCurrent	Single faultcondition	N/A	N/A
Number of Output Modes		TENS: 15	15 Modes (01-15)	Different butdoes notadversely impactsafety andeffectiveness ofsubject device
	SynchronousOrAlternating	2 Synchronous	2 Synchronous	Same
Number ofOutputChannels	Method ofChannelIsolation	By electrical circuit andsoftware	PCB InsulationBoost Isolation	Different butdoes notadversely impactsafety andeffectiveness ofsubject device
Regulated Current orRegulated Voltage?		Regulated voltage	Regulated voltage	Same
Software/Firmware/Microprocessor Control?		Yes	Yes	Same
Automatic Overload Trip?		Yes	No	Different but

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				does notadversely impactsafety andeffectiveness ofsubject device
Automatic No-Load Trip?		Yes	Yes	Same
Automatic Shut Off?		Yes	Yes	Same
User Override Control?		Yes	Yes	Same
	On/OffStatus	Yes	Yes	Same
	Low Battery	Yes	Yes	Same
IndicatorDisplay	Voltage/CurrentLevel	Yes	Yes for voltage	Similar and doesnot impact safetyand effectivenessof subject device
Timer Range (minutes)		5-100 minutes	5-100 minutes	Same
Compliance with VoluntaryStandards		IEC 60601-1,IEC 60601-1-2,IEC 60601-2-10,ISO10993-5/10	IEC 60601-1,IEC 60601-1-2,IEC 60601-2-10,ISO10993-5/10	Same
Compliance with 21 CFR898-7		Yes	Yes	Same
Weight		89 g (including belt clip,without batteries),123 g (including belt clipand batteries)	101 g (including belt chip)	Slightly differentbut does notimpact safety andeffectiveness ofsubject device
Dimensions [W x H x D]		132 x 63 x 29.5 mm(including belt clip)	132 x 63 x 29.5 mm(including belt clip)	Same
Housing Materials andConstruction		ABS	ABS	Same
Output Specifications
Waveform (e.g., pulsedmonophasic, biphasic)		Biphasic	Biphasic	Same
Shape (e.g., rectangular,spike, rectified sinusoidal)		Square	Square	Same
MaximumOutput Voltage(Volts, Vpp)	@500Ω	100±10%	70±15%	Different butdoes notadversely impactsafety andeffectiveness ofsubject device
	@2KΩ	180±10%	110±15%
	@10KΩ	250±10%	190±15%
MaximumOutput Current(mA)	@500Ω	200±10%	86±15%	Different butdoes notadversely impactsafety andeffectiveness ofsubject device
	@2KΩ	90±10%	23.3±15%
	@10KΩ	25±10%	3.75±15%
Duration of primary phase		50-450μS	0	Different butdoes notadversely impactsafety andeffectiveness ofsubject device
Pulse Duration		50-450μS	50-360μS	Different butdoes notadversely impactsafety andeffectiveness ofsubject device
Frequency		1-150Hz	1-150Hz	Same
Formulti-program	SymmetricalPhases?	N/A	N/A	Same
waveformsonly	PhaseDuration
Net charge (micro coulombsμC) (per pulse)	$0.001μC@500Ω$	$0.001μC @500Ω$	Same
Max. phase charge (mC)	$0.045@500Ω$	$0.0454@500Ω$	Different butdoes notadversely impactsafety andeffectiveness ofsubject device
Max. current Density(mA/cm², r.m.s)	$0.667@500Ω$	$0.790@500Ω$	Different butdoes notadversely impactsafety andeffectiveness ofsubject device
Max. Average current(average absolute value),mA	$13.5@500Ω$	$16.0@500Ω$	Different butdoes notadversely impactsafety andeffectiveness ofsubject device
Max. Average PowerDensity, W/cm² (usingsmallest electrodeconductive surface area)	$0.0046@500Ω$	$0.00632@500Ω$	Different butdoes notadversely impactsafety andeffectiveness ofsubject device
BurstMode(i.e.pulse	(a) Pulses per burst	3	4	Different butdoes notadversely impactsafety and
	(b) Bursts persecond	2/60Hz	4/83Hz	adversely impactsafety and
	(c) Burst duration	36ms	0.18ms	safety and
trains)	(d) Duty cycle	36ms/390ms	35ms/60ms	effectiveness ofsubject device
	ON Time (seconds)	2	2	Same
	OFF Time (seconds)	2	2	Same
	Electrode area	20.25sqcm x4 (81sqcm)	20.25sqcm x4 (81sqcm)	Same
	Average DC current throughelectrodes when device is onbut no pulses are beingapplied (µA)	0	0	Same

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Traditional 510(k), K171803/AIR Section 5 - 510(k) Summary

5.11 Similarity and Difference

The HIVOX OTC Electrical Stimulator (SEM44, SEM44-1) has been compared with "OTC Electrical stimulator Models MT9001, LT3060" and "Tyece OTC TENS Device, Model SEM44" respectively. The subject device has similar intended use, technological characteristics and same principle of operation as these predicate devices. Although there are several specifications that are different between two devices, the comparison analysis has been completed to demonstrate that the differences between these parameters would not adversely impact the safety and effectiveness of the subject device. The subject device has undergone safety and performance tests, and the results complied with the test requests. Therefore, the difference between the subject device and the predicate devices did not raise any problem of substantial equivalence. The subject device is substantially equivalent to the predicate devices in intended use, safety and performance claims.

5.12 Conclusion

After analyzing non-clinical laboratory studies and safety testing data, it can be concluded that the HIVOX OTC Electrical Stimulator (SEM44, SEM44-1) is substantially equivalent to the predicate devices.

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).