The 2-in-1 Abdominal Muscle Training & Back Pain Relief System has two modes of stimulation; a transcutaneous electrical nerve stimulation (TENS) BP-313 mode and a powered muscle stimulation (PMS) TS-212 mode.

The TENS (BP-313 Mode) is indicated for temporary relief of pain associated with sore and aching muscles in the waist. back, arm, leg due to strain from exercise or normal household and work activities.

The PMS (TS-212 Mode) is indicated for the improvement of abdominal muscle tone, for strengthening of abdominal muscles and for the development of a firmer abdomen. This system is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.

Device Description

2-in-1 Abdominal Muscle Training & Back Pain Relief System has 12 operation modes, which can give certain electrical pulse through 4 of electrode pads placed on the skin to help users to enjoy body stimulation.

The support belt which fastens around your waist provides appropriate stimulation position for a quick and easy exercise for users of all different waist sizes. The adhesive pads adhere to the belt to conduct the signal from the unit to your abdominal muscles. Snap cables are for connecting the stimulator and the support belt. Each unit comes with one battery (6F22/1604) so you can start exercising right away.

AI/ML Overview

The provided document is a 510(k) Summary for a medical device called "2-in-1 Abdominal Muscle Training & Back Pain Relief System." This type of document is submitted to the FDA to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. As such, it focuses on comparing the new device to existing ones rather than detailing a specific clinical study for the new device's performance against defined acceptance criteria in the format requested.

Therefore, the specific information about detailed acceptance criteria, a dedicated study proving performance, sample sizes for test/training sets, experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for this specific device's clinical performance is not present in the provided text.

The document primarily outlines design validation tests performed to ensure electrical safety, electromagnetic compatibility, biocompatibility, and software functionality, as well as a waveform test to verify output specifications. These are essential for establishing substantial equivalence but are not clinical performance studies with acceptance criteria in the sense of demonstrating diagnostic accuracy or treatment efficacy in human subjects.

However, I can extract information related to the tests performed and the standards they comply with:

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

The document does not provide specific quantitative acceptance criteria or reported device performance in the format of a clinical trial. Instead, it states that the device was evaluated against various standards. The "performance" in this context refers to compliance with these standards and the device's technical specifications.

Test Category	Acceptance Criteria (Stated as Compliance Standard)	Reported Device Performance
Electrical Safety	IEC 60601-1 and IEC 60601-2-10 standards	Complies with IEC 60601-1 and IEC 60601-2-10 requirements.
Electromagnetic Compatibility	IEC 60601-1-2 standard	Complies with IEC 60601-1-2 requirements.
Biocompatibility	ISO 10993-5 and ISO 10993-10 standards	Complies with ISO 10993-5 and ISO 10993-10 requirements for user-contacting materials.
Software Verification/Validation	FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices"	Complies with FDA guidance requirements.
Waveform Test (Output Specifications)	FDA "Guidance for Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use" and "Guidance for Powered Muscle Stimulator for Muscle Conditioning"	Verified output specifications according to FDA guidance. (Specific parameters like Voltage, Current, Pulse Duration, etc., are compared to predicate devices and deemed compliant with standards/guidance).
Patient Leakage Current	Comply with IEC 60601-1 and IEC 60601-2-10	AC: 54.5µA, DC: 0.5µA (Subject Device) vs. Comply with IEC 60601-1 and IEC 60601-2-10 (Predicate)
Average DC current through electrodes (no pulses)	Comply with IEC 60601-1 and IEC 60601-2-10	0A (Subject Device) vs. < 0.01μA (Predicate)

Notes on the "Reported Device Performance" for Output Specifications:
The document provides detailed technical specifications for the subject device and predicate devices (e.g., Maximum Output Voltage, Maximum Output Current, Pulse Duration, Pulse Frequency, Net Charge, etc.). It states that "Although the... are a little different from the predicate devices, they all comply with IEC 60601-1, IEC 60601-2-10 requirement for Transcutaneous Electrical Nerve Stimulator for Pain Relief and FDA guidance requirement for Powered Muscle Stimulator for Muscle Conditioning." This implies that the device's performance on these specific electrical parameters meets the established regulatory and guidance thresholds, even if they differ numerically from the predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document describes engineering and bench testing, not clinical studies involving human subjects with test sets in the traditional sense.

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. Ground truth for clinical performance is not established as this is not a clinical study. The "truth" in this context refers to compliance with international standards and FDA guidance through lab testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a clinical study requiring adjudication.

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 device is an electrical stimulator, not an AI-assisted diagnostic or treatment planning tool that would typically involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device, not an algorithm. Its performance is evaluated through bench testing and compliance with standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" or reference standard for the device's design and technical specifications is compliance with established international medical device standards (IEC 60601-1, IEC 60601-2-10, ISO 10993-5, ISO 10993-10, IEC 60601-1-2) and relevant FDA guidance documents for Transcutaneous Electrical Nerve Stimulators and Powered Muscle Stimulators.

8. The sample size for the training set
Not applicable. There is no mention of a training set for an algorithm in this document, as it describes a physical electrical stimulator.

9. How the ground truth for the training set was established
Not applicable, as there is no training set mentioned.

Summary

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Image /page/0/Picture/1 description: The image shows a logo with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around a circular seal. Inside the seal is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, creating a sense of depth and unity. The logo is simple and professional, conveying a sense of authority and trustworthiness.

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

December 23, 2015

Tohkai Precision Electrical Manufactory (Shenzhen) Limited c/o Ms. Cecilia Ceng Guangzhou GLOMED Biological Technology Co., Ltd. Suite 306. Kecheng Mansion No. 121 Science Road Guangzhou Science Park Guangzhou, Guangdong, 510663 China

Re: K152128

Trade Name: 2-in-1 Abdominal Muscle Training & Back Pain Relief System Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH, NGX Dated: November 18, 2015 Received: November 23, 2015

Dear Ms. Ceng:

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 27f 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

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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 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Small Manufacturers, International and Consumer Assistance 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,

William J. Heetderks -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) K152128

Device Name

2-in-1 Abdominal Muscle Training & Back Pain Relief System

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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Tohkai Precision Electrical Manufactory (Shenzhen) Limited Sponsor: Subject Device: 2-in-1 Abdominal Muscle Training & Back Pain Relief System

510 (k) Summary

Chapter 5. 510(k) Summary

510(k) Summary

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

1. 510 (k) submitter

Company Name: Tohkai Precision Electrical Manufactory (Shenzhen) Limited
Establishment Registration Number: Applying
Address: No.3 Alley 1,Second Industrial Park, Jia Zi Tang, GongMing Office. GuangMing New ● Developed Area. ShenZhen.
Postal Code: 518132
Phone: 0755-27173101
Fax: 0755-27173105
Contact Person (including title): Yuk Wing Li (General Manager)
E-mail: tohkaip@globalsoures.com

2. Application Correspondent

Contact Person: Ms. Cecilia Ceng / Mr. Tim Wong
Guangzhou GLOMED Biological Technology Co., Ltd. ●
Tel: +86-20-61099984
Email: regulatory@glomed-info.com

3. Subject Device Information:

Common Name: Electronic Stimulator
Trade Name: 2-in-1 Abdominal Muscle Training & Back Pain Relief System
. Classification Name: Stimulator, Nerve, Transcutaneous, Muscle, Powered, For Muscle Conditioning, Over-The-Counter
Review Panel: Neurology & Physical Medicine
Product Code: NUH, NGX +
. Regulation Number: 882.5890, 890.5850
Regulation Class: II

4. Predicate Device Information

	LETO ENTERPRISESINCORPORATION	Endurance Therapeutics	Shenzhen OSTOTechnology CompanyLimited
Sponsor
DeviceName andModel	X2ABS Dual ChannelFitness Belt	TI040	Health ExpertElectronicStimulatorModel: AST-300C and

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Sponsor:	Tohkai Precision Electrical Manufactory (Shenzhen) Limited
Subject Device:	2-in-1 Abdominal Muscle Training & Back Pain Relief System

			AST-300D
510(k)Number	K102295	K060846	K133929
ProductCode	NGX	NGX, NUH, GZJ	NUH, NGX
RegulationNumber	890.5850	882.5890	882.5890, 890.5850
RegulationClass	II	II	II

Device Description 5.

TS-212:

Its technology allows you to exercise ALL of the abdominal muscles using a simple belt. A signal is sent from the belt to the nerves which control the muscles. These nerves are stimulated in the area where they are most concentrated using the model of TS-212, causing a deep, comfortable contraction of the muscles of the abdomen.

You will feel a mild pulsing sensation, followed by some tightening of the skin and muscle between the pads. The muscles should contract smoothly, hold themselves in a tensed position for a few seconds and then gently relax again. If you feel a sharp prickling sensation or no feeling you should refer to the trouble shooting guide it may be that the pads are positioned directly over your hip bones and need repositioning. Once the problem is solved, just continue with your exercise.

BP-313:

The main function of pain relief comes from the continuous stimulation pulse generated from the dual channel stimulator. We cannot ensure that the pain relief is 100% effective for everyone. However, when used according to our instruction, it can be a safe, non-invasive lower back pain reliever.

Transcutaneous Electrical Nerve Stimulation (TENS) relieves pain by sending small electrical impulses through electrodes placed on the skin to underlying nerve fibers. TENS is believed to work by two different mechanisms. First, electrical stimulation of the nerve fibers can block a pain signal from

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Sponsor:	Tohkai Precision Electrical Manufactory (Shenzhen) Limited
Subject Device:	2-in-1 Abdominal Muscle Training & Back Pain Relief System

being carried to the brain. If the signal is blocked, pain is not perceived. Secondly, the body has its own mechanism for suppressing pain. It does this by releasing natural chemicals called endorphins in the brain which act as analgesics. TENS may activate this mechanism.

Intended Use 6.

The 2-in-1 Abdominal Muscle Training & Back Pain Relief System has two intended uses; The powered muscle stimulation (PMS) Mode (TS-212) is intended to deliver electrical stimulation to the muscles of the abdomen.

The transcutaneous electrical nerve stimulation TENS Mode (BP-313) is intended to deliver electrical stimulation to the peripheral nerves of the body.

7. Indications for Use

The TENS(BP-313 Mode) is indicated for temporary relief of pain associated with sore and aching muscles in the waist, back, arm, leg due to strain from exercise or normal household and work activities.

THE PMS (TS-212 Mode) is indicated for the improvement of abdominal muscle tone, for strengthening of abdominal muscles and for the development of a firmer abdomen. This system is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.

8. Design

2-in-1 Abdominal Muscle Training & Back Pain Relief System is a portable multifunctional device, offering both Transcutaneous Electronic Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) qualities. 2-in-1 Abdominal Muscle Training & Back Pain Relief System has 12 operation modes, which can give certain electrical pulse through 4 electrode pads placed on the skin to help users to enjoy body stimulation. It is comprised of a main device for signal generation, belts for fixation, and series electrodes. The electronic stimulatory module has the operating elements of ON/OFF Switch, Model Selection knob, Display screen, Mode Selection key and Intensity Modification keys.

The device is chosen function between TENS(BP-313, Mode 1-8) and PMS(TS-212, Mode 1-4) before turning on the system.

The LCD display screen can show selected mode, output intensity of body, and time remaining of an application mode.

The device is equipped with accessories of electrode pads, snap cable, gel sticks, support belt. The snap cable is used to connect the pads to the main unit. All the accessories, including electrode pads, snap cable, gel sticks, support belt can only be changed by special person.

9. Materials

There are two user directly contracting components in the subject device as the following list.

Patient ContactingComponents	Material	Body ContactLocation	Contact Duration
Button	ABS PA-757PMMA-CM211	Surface-contactingdevice: skin	Less than 30 min
Connect line	SR8000-70N	Surface-contactingdevice: skin	Less than 30 min

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Sponsor:	Tohkai Precision Electrical Manufactory (Shenzhen) Limited
Subject Device:	2-in-1 Abdominal Muscle Training & Back Pain Relief System

	510(k) Summary
--	----------------

	TPR RN-100PVC03
Belt	conductive fabric	Surface-contactingdevice: skin	5 – 30 min (dependson patients' setting)
Electrode Pads	gel	Surface-contactingdevice: skin	5-30 min (dependson patients' setting)
Unit Housing	ABS plastic	Surface-contactingdevice: skin	Less than 30 min

10. Specification

Power Source	1 x 6F22 battery (9 Volt)
Number of channels	Two channels
Number of programs	TENS (BP-313): 8PMS (TS-212): 4
Output intensity level	Blevel
Frequency	2Hz-120Hz
Pulse Duration	$16\mu s$ -260 $\mu s$
Contraction andrelaxation time	Adjustable, due to different modes. (See below "ProgramSpecification Table")
Treatment time	5-30 minutes
Indicator display	On/Off Status, Low Battery, Channel, Mode, Time
Electrode size	Electrode pad: 50mm(diameter) • 1.5mm(thickness).gel stick : 48.048.01.5mm
Control unit dimension	125 x 72 x 39.5mm
Weight	Approx. 150g (battery included)
Environment foroperation	Temperature: +41"Fto+104"F (+5'Cto +40'C);Humidity: 15% to 93% RH
Environment forstorage	Temperature: -13"Fto+158"F (-25'Cto +70'C);Humidity: ,;93% RH

11. Test Summary

2-in-1 Abdominal Muscle Training & Back Pain Relief System has been evaluated the safety and performance by lab bench testing as following:

Electrical safety test according to IEC 60601-1 and IEC 60601-2-10 standards .
. Electromagnetic compatibility test according to IEC 60601-1-2 standard
Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards
Software verification and validation test according to the requirements of the FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices"

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Sponsor:	Tohkai Precision Electrical Manufactory (Shenzhen) Limited
Subject Device:	2-in-1 Abdominal Muscle Training & Back Pain Relief System

The waveform test report has also been conducted to verify the output specifications of the device according to Guidance for Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use and Guidance for Powered Muscle Stimulator for Muscle Conditioning

12. Comparison to predicate device and conclusion

The technological characteristics, features, specifications, mode of operation, and intended use of 2-in-1 Abdominal Muscle Training & Back Pain Relief System is substantially equivalent to the predicate devices quoted above.

The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.

Elements ofComparison	Subject Device	Predicate Device	Remark
Manufacturer	Tohkai PrecisionElectricalManufactory(Shenzhen) Ltd.	LETOENTERPRISESINCORPORATIONEnduranceTherapeuticsShenzhen OSTOTechnologyCompany Limited	--
Device Name andModel	2-in-1 AbdominalMuscle Training &Back Pain ReliefSystem	X2ABS Dual ChannelFitness BeltTI 040Shenzhen OSTOTechnologyCompany Limited	--
510(k) Number	Applying	K102295 K060846 K133929	--
Basic Unit Characteristics
Power Source(s)	1 x 6F22 battery (9Volt)	2 x 1.5V AAAbatteries4.5 Volt batteryAdaptor Input: 100-240Vac, 50-60Hz,0.1AOutput: 5Vdc, 1AUnit Input: 5Vdc, 1A	SENote1
-Method of LineCurrent Isolation	Type BF Applied Part	Type BF AppliedPartType BF AppliedPart	SE
PatientLeakageCurrent	NCSFC	Comply with IEC60601-1 and IEC60601-2-10Comply with IEC60601-1 and IEC60601-2-10	AC: 54.5µA, DC:0.5µAAC:120.0µA, DC:0.6µA	SENote 1

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Sponsor:	Tohkai Precision Electrical Manufactory (Shenzhen) Limited
Subject Device:	2-in-1 Abdominal Muscle Training & Back Pain Relief System

Average DCcurrent throughelectrodes whenDevice is on butno pulses arebeing delivered.	0A		0 A	< 0.01μΑ	SENote 1
Elements ofComparison	Subject Device		Predicate Device		Remark
device is on butno pulses arebeing applied
Number ofOutput Channels:	2	2	1	2	SENote 1
Number of OutputModes	TENS (BP-313): 8PMS (TS-212): 4	8	10	25	SENote 2
Output IntensityLevel	8 steps	28 steps		99 steps	SENote 2
Synchronous orAlternating	Synchronous	Synchronous	Synchronous	Synchronous	SENote 2
Method ofChannel Isolation	Voltage TransformIsolation	Up / down button ofleft or right channel	On/Off Switch	Voltage TransformIsolation"BODY▼" and" BODY▼" buttonsfor body channel," SOLE ▲" and"SOLE ▼" buttonsfor feet channel	SENote 2
Regulated Currentor RegulatedVoltage	Voltage Control	Regulated Voltage	Voltage Control	Voltage Control	SE
Software/Firmware/MicroprocessorControl?	Yes		Yes	Yes	SE
AutomaticOverload Trip	No	No	No	No	SE

{9}------------------------------------------------

Sponsor:	Tohkai Precision Electrical Manufactory (Shenzhen) Limited
Subject Device:	2-in-1 Abdominal Muscle Training & Back Pain Relief System

	510(k) Summary
Automatic No-Load Trip	Yes. The unit will not work and the icon of the corresponding unit will twinkle if no load is connected.	Yes. The unit will not work and the unit will sound a beeping alarm if no load is connected.	No	No	SE Note 2

Elements ofComparison	Subject Device	Predicate Device	Remark
Automatic ShutOff	Yes	After approximately10 minutes, theAUTO OFF functionwill turn off the unit, ifit is not in use.	No	Yes	SE
User OverrideControl	Yes	Yes	Yes	Yes	SE
Indicator On/OffDisplay	Status	Yes	Yes	Yes	Yes	SE
	LowBattery	Yes	Yes	Yes	No	SENote 2
	Voltage/CurrentLevel	Yes	Yes	No	Yes	SENote 2
Timer Range		adjustable from 5 -30 minutes	Default time is 10minutes, minimumtime is 5	--	Yes	SENote 2
Weight		Approx. 150g (batteryincluded)	81.2g (with battery)	14.4 oz	2Kg (Withoutaccessories)	SENote 2
Dimensions		125 x 72 x 39.5mm	82 mm (L) X 62 mm(W) X 23 mm (H)	6 in(W)1 in(H)2.8in(D)	428mm x 428.8mmx 185mm	SENote 2
Housing Materialsand Construction		Main unit: ABSplastic	--	ABS	Main unit: ABSplastic	SE
Output Specifications
Waveform		TENS (BP-313):MonophasicPMS (TS-212):Biphasic	Biphasic	Biphasic	Pulsed, symmetric,biphasic	SE

{10}------------------------------------------------

Sponsor:	Tohkai Precision Electrical Manufactory (Shenzhen) Limited
Subject Device:	2-in-1 Abdominal Muscle Training & Back Pain Relief System

Shape	Rectangular	Rectangular	Rectangular	Rectangular, withinterphase interva	SE
Maximum OutputVoltage	42V±10% @ 500Ω	From 0 to 60 mA(From 0 to 1000 Ω)	40.7V±20% @ 500 Ω	44V±10% @ 500Ω	SENote 3
	78V±10% @ 2ΚΩ		105.1V±20% @ 2 kΩ	80V±10% @ 2ΚΩ
	94V±10% @ 10ΚΩ		154.1V±20% @10 kΩ	112V±10% @10ΚΩ
Maximum OutputCurrent	84mA±10% @ 500Ω	--	81.4mA±20% @ 500 Ω	88mA±10% @ 500Ω	SENote 3
	39mA±10% @ 2ΚΩ		47.8mA±20% @ 2 kΩ	40mA±10% @ 2ΚΩ
	9.4mA±10% @ 10ΚΩ		15.4mA±10% @10 kΩ	11.2mA±10% @ 10ΚΩ
Pulse Duration	16μs ~260μs	200μs	4.1–500ms	120μs	SENote 3
Pulse frequency	2Hz-120Hz	8.5~64Hz	245Hz	77.3Hz	SENote 3
Net charge	21.84μC @ 500Ω	--	4.07μC @ 500Ω	0μC @ 500ΩMethod: Balancedwaveform	SENote 3
Maximum PhaseCharge	21.84µC @ 500Ω	--	16.90μC @ 500Ω	12.78μC @ 500Ω	SENote 3
MaximumAverage Current	2.25mA @ 500Ω	--	4.25 mA	0.968mA @ 500Ω	SENote 3
Maximum CurrentDensity(r.m.s )	0.153mA/ cm2(without DC current )	0.032(for the smallest sizeelectrode 32.0 cm²)	2.71mA/cm² @500Ω	0.235mA/cm² @ 500Ω	SENote 3
MaximumAverage PowerDensity	0.232mW/cm²500Ω	@ 0.23W/cm² @ 500Ω	5.35mW/cm²	1.38mW/cm² @ 500Ω	SENote 3
ON Time	1s	1s	--	0.6s	SENote 3
OFF Time	10ms	2s	--	0.6s	SENote 3
Additional Features
Environment foroperating	Temperature: +41°Fto+104°F (+5°C to+40℃);Humidity: 15% to93% RH	Temperature: 5 ~ 40° CHumidity: 20 ~ 65% RH		Temperature: 5 ~ 45°CHumidity: 20 ~ 65% RH	SENote 1

{11}------------------------------------------------

Sponsor:	Tohkai Precision Electrical Manufactory (Shenzhen) Limited
Subject Device:	2-in-1 Abdominal Muscle Training & Back Pain Relief System

510(k) Summary
Environment forstorage	Temperature: -13°Fto+158°F (-25°C to+70°C);	Temperature: 0 ~ 40°CHumidity: 10 ~ 90%		Temperature: 0 ~45°C,Humidity: 10 ~ 90%	SENote 1
Elements ofComparison	Subject Device		Predicate Device		Remark
	Humidity: ≤93% RH	RH		RHElectrode Pad:10~20°C
Standards
Biocompatibility	All user directlycontacting materialsare compliance withISO10993-5 andISO10993-10requirements.	All user directlycontacting materialsare compliance withISO10993-5 andISO10993-10requirements.	--	All user directlycontacting materialsare compliance withISO10993-5 andISO10993-10requirements.	SE
Electrical Safety	Comply with IEC60601-1 and IEC60601-2-10	Comply with IEC60601-1 and IEC60601-2-10	--	Comply with IEC60601-1 and IEC60601-2-10	SE
EMC	Comply with IEC60601-1-2	Comply with IEC60601-1-2	--	Comply with IEC60601-1-2	SE

Programs

	Program	Maximum	Phase Duration	Rate
BP-313(TENS)	1	84mA	260 μs	16Hz
	2	84mA	260 μs	100Hz
	3	50mA	260 μs	120Hz
	4	80mA	260~160 μs	2Hz~100Hz
	5	54mA	260~160 μs	100Hz
	6	80mA	260 μs	80<->10 Hz
	7	52mA	260~160 μs	120Hz
	8	84mA	P1~P7	Cycle
TS-212(PMS)	1	52mA	200 μs	70Hz
	2	52mA	200 μs	60Hz
	3	52mA	200 μs	50Hz
	4	52mA	200 μs	50Hz

{12}------------------------------------------------

Sponsor:	Tohkai Precision Electrical Manufactory (Shenzhen) Limited
Subject Device:	2-in-1 Abdominal Muscle Training & Back Pain Relief System

Comparison in Detail(s):

Note 1:

Although the " Power Source(s)", " Patient Leakage Current through electrodes when device is on but no pulses are being applied", "Operating Environment" are a little different from the predicate devices, they all comply with IEC 60601-1 requirements. So the differences will not raise any safety or effectiveness issue.

Note 2:

Although the " Number of Output Intensity Level", " Method of Channel Isolation", " Timer Range", "Vleight" and "Dimensions" of subject device are different from the predicate devices, they are all comply with IEC 60601-1 and IEC 60601-2-10 requirements. So the differences of the function specifications will not raise any safety or effectiveness issue.

Note 3:

Although the "Maximum Output Voltage", "Maximum Output Current", "Maximum pulse frequency", "Net Charge (per pulse)", "Maximum Phase Charge", "Maximum Average Current", "Maximum Current Density", "Maximum Average Power Density of subject device", "ON Time" are a little different from the predicate devices, they all comply with IEC 60601-1, IEC 60601-2-10 requirement for Transcutaneous Electical Nerve Stimulator for Pain Relief and FDA guidance requirement for Powered Muscle Stimulator for Muscle Conditioning. So the differences of function specification will not raise any safety or effectiveness issue.

Finial Conclusion:

The subject device 2-in-1 Abdominal Muscle Training & Back Pain Relief System has all features of the predicate devices. The differences between them do not affectiveness. Thus, the subject device is substantially equivalent to the predicate devices.

13. Date of the summary prepared: December 16, 2015

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).