These Electrical Muscle Stimulation units are indicated for the improvement of muscle tone and firmness, for strengthening muscles in arms, abdomen, thighs, and buttocks areas. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.

Device Description

SP-910 / SP-920 / SP-620 are 1-channel battery-operated user-friendly muscle stimulation systems specifically designed to exercise the muscles. Each device comprises namely an electronic stimulator module which generates the required stimulation signals. SP-910/620 comprises 2 electrodes, which connects the signals from the stimulator to the skin. SP-920 comprises 4 electrodes, which connects the signals from the stimulator to the skin. Power is supplied from one battery, CR2032, located in a compartment protected by a removable battery cover. The user cannot access the wiring or connectors.

AI/ML Overview

The provided document is a 510(k) summary for the HIVOX Spopad EMS SP-910, SP-920, and SP-620, which are powered muscle stimulators. This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a standalone study with defined acceptance criteria and performance results in the way a clinical trial might.

Therefore, the information requested about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment (as typically found in AI/ML device evaluations) is not present in this 510(k) summary. These devices are much simpler than AI-powered diagnostic tools and rely on established electrical safety and performance standards for their regulatory clearance.

However, I can extract the relevant comparison information that serves as the basis for the declaration of substantial equivalence, which implicitly acts as the "criteria" for approval in this context.

Here's a summary based on the provided text, aligning with your request where possible, and noting when information is unavailable:

Acceptance Criteria and Device Performance (Implicit from Predicate Comparison)

For a 510(k) submission, the "acceptance criteria" are generally met by demonstrating that the new device is as safe and effective as a legally marketed predicate device. The following table summarizes the comparison made by the manufacturer. The reported device performance is presented in comparison to the predicate, with the conclusion that differences are minor and do not raise new safety or effectiveness concerns.

Feature/Parameter	Acceptance Criteria (Predicate Device K092476, Model 4M)	Reported Performance (HIVOX Spopad EMS SP-910, SP-920, SP-620)
Intended Use	Improvement of muscle tone/firmness, strengthening muscles in arms, abdomen, thighs, buttocks; Not for therapy or treatment of medical conditions.	Improvement of muscle tone/firmness, strengthening muscles in arms, abdomen, thighs, buttocks; Not for therapy or treatment of medical conditions. (Same)
Technology	Electrical Muscle Stimulation	Electrical Muscle Stimulation (Same)
Power Source	1.5V battery * 3	3V Battery * 1
Method of Line Current Isolation	Battery supply	Battery Supply (Same)
Patient Leakage Current (Normal Condition)	< 3 µA	2.0 µA (SP-920)
Patient Leakage Current (Single Fault Condition)	< 4 µA	2.1 µA (SP-920)
Method of channel isolation	Software	1 channel
Average DC current through electrodes (device on, no pulses)	0 µA	0 µA (Same)
Number of output modes	1	1 (Same)
Regulated current or voltage?	Voltage	Voltage (Same)
Software/firmware/Microprocessor control?	Yes	Yes (Same)
Automatic overload trip?	No	No (Same)
Automatic no-load trip?	No	No (Same)
Automatic shut-off?	Yes	Yes (Same)
User overrides control?	Yes	Yes (Same)
Indicator display - On/Off Status	Yes	No
Indicator display – Low battery?	Yes	No
Indicator display – Voltage/Current	No	No (Same)
Timer Range (minutes)	N/A	20
Compliance with voluntary standards?	IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2, IEC 60601-1-4	IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2
Compliance with 21 CFR 898?	Yes	Yes (Same)
Housing material and construction	ABS	Silicone
Output waveform	Monophasic	Symmetrical biphasic
Shape	Rectangular	Rectangular (Same)
Duration of primary (depolarizing) phase	0	0 (Same)
Pulse duration (µSec)	N/A	400
Maximum output voltage (V, +/-10%) at 500 ohms	N/A	52, 58.4, 60 (for SP-910, SP-920, SP-620 respectively)
Maximum output voltage (V, +/-10%) at 2k ohms	N/A	102, 106, 109
Maximum output voltage (V, +/-10%) at 10k ohms	N/A	150, 146, 140
Maximum output current (mA, +/-10%) at 500 ohms	N/A	104, 117, 120
Maximum output current (mA, +/-10%) at 2k ohms	N/A	51, 53, 54.5
Maximum output current (mA, +/-10%) at 10k ohms	N/A	15, 14.6, 14
Frequency (Hz)	N/A	SP-910: 3/4/5; SP-920/SP-620: 2/4/25
Net charge per pulse at 500 ohms (µC)	N/A	0.416, 0.468, 0.960
Maximum charge at 500 ohms (µC)	N/A	41.6, 46.8, 48
Maximum current density at 500 ohms (mA/cm²)	< 2	1.328, 1.057, 1.952
Maximum average power density at 500 ohms (W/cm²)	< 0.25	0.0691, 0.0617, 0.117
Burst mode (Pulse per burst)	N/A	25 (for SP-620)
Burst mode (Burst per second)	N/A	1 (for SP-620)
Burst mode (Burst duration (sec))	N/A	20 (for SP-620)
Burst mode (Duty cycle)	N/A	20 (for SP-620)

Detailed information based on your numbered points:

A table of acceptance criteria and the reported device performance: See the table above. The "acceptance criteria" are implicitly defined by the characteristics of the predicate device and relevant industry standards. The reported performance of the HIVOX devices is compared against these implicit criteria.
Sample sizes used for the test set and the data provenance:
- Not Applicable. This 510(k) summary does not describe a clinical study or a test set in the conventional sense for evaluating a diagnostic or AI device. The comparison is based on the technical specifications of the device and its predicate, and compliance with performance and safety standards.
- The document implies that the devices meet IEC electrical safety standards (IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2) which involve specific tests, but the sample sizes for these standard compliance tests are not specified in this summary.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. No ground truth in the context of expert review for medical imaging or AI performance is mentioned. This device is a muscle stimulator, not an AI diagnostic tool.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. No such adjudication method is mentioned or relevant for this type of device submission.
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 is not an AI-assisted device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm-only or AI device. The "standalone" performance refers to the device's electrical output characteristics and its compliance with safety standards, which are evaluated without human intervention in the loop of its function (though a human operates the device).
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. For a powered muscle stimulator, "ground truth" is typically defined by adherence to engineering specifications and electrical safety standards (e.g., measured current, voltage, frequency must be within specified ranges and below safety limits). The document states that the devices (both predicate and subject) "pass medical device electric safety standard, IEC 60601-1 and standard for Nerve and Muscle Stimulator, IEC 60601-2-10 and electromagnetic compatibility standard IEC 60601-1-2." This compliance with standards serves as the "ground truth" for safety and basic performance.
The sample size for the training set:
- Not Applicable. This product is a physical electrical muscle stimulator, not an AI/ML product that undergoes training.
How the ground truth for the training set was established:
- Not Applicable. As there is no training set for an AI/ML model, this question is not relevant.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing right, connected by flowing lines that resemble ribbons or streams. The profiles are arranged in a staggered formation, with the first profile being the largest and the subsequent profiles gradually decreasing in size. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 16, 2015

HIVOX BIOTEK, INC. Ke-Min Jen. Official Correspondent 5 F., No. 123 Shingde Road San-chong District New Taipei City. TW 24158

Re: K141921

Trade/Device Name: HIVOX Spopad EMS SP-910, SP-920, SP-620 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: December 7, 2014 Received: December 11, 2014

Dear Dr. Jen. Ke-Min:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) 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" (21CFR 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,

Felipe Aquel -S

Carlos L. Peña, PhD, MS for 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) K141921

Device Name HIVOX Spopad EMS SP-910, SP-920, SP-620

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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Image /page/3/Picture/0 description: The image shows the word "HIVOX" in a sans-serif font. The letters are black, and there is a registered trademark symbol after the "X". To the right of the word is a plus sign made up of four squares. The top left square is green, and the bottom right square is blue.

5. 510(k) SUMMARY (According to 21 CFR 807.92)

●	510(K) OWNER'SHIVOX BIOTEK INC.
	NAME	5F, No.123, Shingde Road, Sanchong Dist.,New Taipei City, 24158, TAIWAN, R.O.C.
		TEL: +886-2-85112668 FAX:+886-2-85112669
●	Name Of ContactPerson	Dr. JEN, KE-MINTEL: 886-2-85112668 FAX:886-3-5209783Email: ceirs.jen@msa.hinet.net
●	Date Of Submission	July 5, 2014
●	Trade Name	HIVOX Spopad EMS SP-910, SP-920, SP-620
●	Common Name	Powered Muscle Stimulator
●	Classification Name	Powered Muscle Stimulator(21 CFR 890.5850, Product Code NGX)
●	Panel	Physical Medicine
●	Intended Use	These Electrical Muscle Stimulation units are indicated for theimprovement of muscle tone and firmness, for strengtheningmuscles in arms, abdomen, thighs, and buttocks areas.Not intended for use in any therapy or for the treatment of anymedical conditions or diseases.
●	Device Design	EMS, Electrical Muscle Stimulation, which improves, tones,firms & strengthens muscle and relaxes stiff muscle through theskin. It is recognized as a clinically proven, effective,non-medication method of training muscle from certain causes.It manages muscle strengthen, toning and firming. It is also freefrom side effects when used properly, and can also be used as asimple means of self-training.

HIVOX Spopad EMS SP series, SP-910 / SP-920 / SP-620 are the proposed subject devices for this 510(k) submission.

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Image /page/4/Picture/0 description: The image shows the word "HIVOX" in bold, black letters. To the right of the word is a plus sign made up of four squares. The top left and bottom right squares are green, and the top right and bottom left squares are blue.

5F., No. 123, Shingde Road, Sanchong District, New Taipei City, Taiwan Phone: +886 2 8511 2668 Fax: +886 2 8511 2669

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5F., No. 123, Shingde Road, Sanchong District, New Taipei City, Taiwan Phone: +886 2 8511 2668 Fax: +886 2 8511 2669

Comparison items	Predicate device 1(PD)	Subject device(1)	Subject device(2)	Subject device(3)
ManufacturerSubmitter	SPORT-ELEC S.A.	HIVOX-BIOTEK
Device name	Body ControlSystem	Spopad EMS, SP series
Model number	4M	SP-910	SP-920	SP-620
510(k) number	K092476	TBA	TBA	TBA
Product code	NGX		NGX
Classification name	Powered MuscleStimulator	Powered Muscle Stimulator
Regulation number	21 CFR 890.5850	21 CFR 890.5850
Indications for use	Indicated for theimprovement ofmuscle tone andfirmness, forstrengtheningmuscles in arms,abdomen, thighsand buttocks areas.Contraindicateduse on injured orotherwise impairedmusclesNot intended foruse in any therapyor for the treatmentof any medicalconditions ordiseases.	Indicated for the improvement of muscle toneand firmness, for strengthening muscles in arms,abdomen, thighs, and buttocks areas.Not intended for use in any therapy or for thetreatment of any medical conditions or diseases.
Technology	Electrical MuscleStimulation	Electrical Muscle Stimulation
Power Source	1.5V battery *3	3V Battery *1
- Method of LineCurrent Isolation	Battery supply	Battery Supply
- Patient LeakageCurrentNormal Condition (µA)	< 3		2.0
Single FaultCondition(µA)	< 4		2.1
Method of channelisolation	Software	1 channel

Compare to Legally Marketed Predicate Devices _

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5F., No. 123, Shingde Road, Sanchong District, New Taipei City, Taiwan Phone: +886 2 8511 2668 Fax: +886 2 8511 2669

Average DC currentthrough electrodes whendevice is on but nopulses are being applied	0 μΑ	0 μΑ
Number of outputmodes	1	1
Regulated current orregulated voltage?	Voltage	Voltage
Software /firmware /Microprocessor control?	Yes	Yes
Automatic overloadtrip?	No	No
Automatic no-load trip?	No	No
Automatic shut-off?	Yes	Yes
User overrides control?	Yes	Yes
Indicator display -On/Off Status	Yes	No
Indicator display – Lowbattery?	Yes	No
Indicator display –Voltage /Current	No	No
Timer Range (minutes)	N/A	20
Compliance withvoluntary standards?	IEC 60601-1IEC 60601-2-10IEC 60601-1-2IEC 60601-1-4	IEC 60601-1IEC 60601-2-10IEC 60601-1-2
Compliance with 21CFR 898?	Yes	Yes
Housing material andconstruction	ABS	Silicone
Output waveform	Monophasic	Symmetrical biphasic
Shape	Rectangular	Rectangular
Duration of primary(depolarizing) phase	0	0
Pulse duration (μSec)	N/A	400
Maximum outputvoltage (Voltage,+/-10%) at 500 ohms	N/A	5258.460
Maximum outputvoltage (Voltage,+/-10%) at 2k ohms	N/A	102106109
Maximum outputvoltage (Voltage,+/-10%) at 10k ohms	N/A	150146140

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Image /page/7/Picture/0 description: The image shows the logo for HIVOX. The logo consists of the word "HIVOX" in black, sans-serif font. To the right of the word is a plus sign made up of four squares. The top left square is green, the top right square is white, the bottom left square is white, and the bottom right square is blue.

5F., No. 123, Shingde Road, Sanchong District, New Taipei City, Taiwan Phone: +886 2 8511 2668 Fax: +886 2 8511 2669

Maximum outputcurrent (mA +/-10%) at500 ohms	N/A	104	117	120
Maximum outputcurrent (mA +/-10%) at2k ohms	N/A	51	53	54.5
Maximum outputcurrent (mA +/-10%) at10k ohms	N/A	15	14.6	14
Frequency (Hz)	N/A	3/4/5	2/4/25	2/4/25
Net charge per pulse at500 ohms (µC)	N/A	0.416	0.468	0.960
Maximum charge at 500ohms (µC)	N/A	41.6	46.8	48
Maximum currentdensity at 500 ohms(mA/cm²)	<2	1.328	1.057	1.952
Maximum averagepower density at 500ohms (W/cm²)	< 0.25	0.0691	0.0617	0.117
Burst mode	A. Pulse per burst	N/A	N/A	25	25
	B. Burst per second	N/A	N/A	1	1
	C. Burst duration (sec)	N/A	N/A	20	20
	D. Duty cycle	N/A	N/A	20	20

Summary of comparison

Basically, the predicate device and Subject Devices are all Over-The-Counter muscle stimulators. Thus, the indications for use for the devices do not differ much.

PD and Subject Devices are all battery-powered, thus electric hazards or safety do not raise much concern, since maximum current / power densities for the devices are all less than 2 (mA/cm2) / 0.25 (W/cm2), which are the FDA recommended ratings. Since the electric output data for PD and Subject Devices only exist minor differences, the minor differences of the electric outputs do not raise any safety and effectiveness aspect. PD and Subject Devices all have the same safety and effectiveness, especially they all pass medical device electric safety standard, IEC 60601-1 and standard for Nerve and Muscle Stimulator, IEC 60601-2-10 and electromagnetic compatibility standard IEC 60601-1-2.

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Image /page/8/Picture/0 description: The image shows the logo for HIVOX. The logo consists of the word "HIVOX" in a bold, sans-serif font, followed by a registered trademark symbol. To the right of the wordmark is a stylized plus sign composed of four squares, two in green and two in blue. The overall design is clean and modern.

5F., No. 123, Shingde Road, Sanchong District, New Taipei City, Taiwan Phone: +886 2 8511 2668 Fax: +886 2 8511 2669

We know that for effectiveness in achieving repeated muscle contractions, powered muscle stimulators typically are capable of stimulating muscle for at least one second per burst, and are capable of providing at least one second of muscle relaxation between successive pulse bursts. PD should meet these requirements. Subject Devices meet these requirements too. PD and Subject Devices are all validating-software processing, thus keeping regular processing parameters and safety functions normal. The Subject Devices have the same effectiveness as the predicate device.

In conclusion, the Subject Devices do not raise any new safety and effectiveness aspect with respect to the PD. Thus the Subject Devices are substantially equivalent to the predicate device.

Regulation Number and Section

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).