Mode 2 (TENS): 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

Device Description

Electronic Pulse Stimulator is a product that adopts modern electronic science and technology to delivers electric pulses generated to the user's skin through the electrodes. It has two modes of different pulse frequencies, mode 1 uses Electrical Muscle Stimulation (EMS) technology for muscle training and mode 2 uses Transcutaneous Electrical Nerve Stimulation (TENS) technology to temporary relieve pain. The device includes operating elements of Power ON/OFF button, intensity increase"+" button, and intensity decrease"-" button and Mode selection button, and could be attached and detached to the electrode pad through the snap-on connector.

In additional, according to different simulation-needed bodies, users can choose the four types of electrode pad based on their own situation. Electronic Pulse Stimulator is suitable for the simulation-needed bodies including hips, arms and legs, abdomen, and feet.

AI/ML Overview

The provided document is a 510(k) Premarket Notification summary for an Electronic Pulse Stimulator (Model S3). It does not contain information about acceptance criteria for a study proving the device meets the acceptance criteria.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and performance data related to existing safety and electrical standards. The "performance data" section primarily discusses compliance with various IEC standards (IEC 60601-1, IEC 60601-1-11, IEC 60601-2-10, IEC 60601-1-2) and biocompatibility testing (ISO 10993-1). There is no mention of a clinical study with specific acceptance criteria that would involve human subjects, expert readers, or a ground truth process as typically defined for performance evaluation of diagnostic or AI-driven medical devices.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the provided text does not contain this type of information. It is a regulatory submission for a simple TENS/EMS device for pain relief and muscle stimulation, not a complex diagnostic system that would involve the kind of performance study you are asking about (e.g., MRMC studies, expert ground truth adjudication).

To directly answer your numbered points based on the absence of such information in this document:

A table of acceptance criteria and the reported device performance: Not provided. The document outlines technological characteristics and compliance with electrical safety and biocompatibility standards, not performance metrics from a study with defined acceptance criteria.
Sample sizes used for the test set and the data provenance: Not applicable. No "test set" in the context of a performance study is described. The "testing" refers to bench testing against industry standards.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment is described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set adjudication is described.
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-driven or diagnostic device, and no MRMC study is mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device does not involve an algorithm with standalone performance in the sense of AI.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. Ground truth for a performance study is not established or discussed.
The sample size for the training set: Not applicable. This device is not described as involving a training set for an algorithm.
How the ground truth for the training set was established: Not applicable. No training set or ground truth establishment for it is described.

The document states that "The electronic pulse stimulator is substantially equivalent to the predicate devices based on intended use, design, specifications and performance." The "performance" here refers to meeting established electrical safety and biocompatibility standards, not a clinical performance validation against a pre-defined ground truth in a study with human subjects.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

Shenzhen Leading Perfection Technology Co., Ltd % Rain Yip Registered Engineer Feiying Drug & Medical Consulting Technical Service Group Rm. 3005. Area B. Bldg.1. Southward Ruifeng Business Center. Guimiao Road Shenzhen, Guangdong 518000 CN

Re: K183674

Trade/Device Name: Electronic Pulse Stimulator, Model S3 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH. NGX Dated: March 30, 2019 Received: September 9, 2019

Dear Rain Yip:

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 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.

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For Vivek Pinto, PhD Director (Acting) DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K183674

Device Name Electronic Pulse Stimulator (Model: S3)

Indications for Use (Describe) Mode 1 (PMS): To be used for stimulating healthy muscles in order to improve and facilitate muscle performance.

Mode 2 (TENS):

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

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

"510(K) Summary" as required by 21CFR 807.92.

Date: 2019-01-25

Submitter I.

Shenzhen Leading Perfection Technology Co., Ltd 4th Floor, J Building, San Yi Dui Industrial Park, Zhoushi Road, Jiuwei, Hangcheng Street, Bao'an District, Shenzhen, China

Tel.: +86 755 2999 1449 Tax: +86 755 2371 3490

Simon Hou (General Manager) Tel: +86 134 8075 8801 Email: info@leadingind.com

II. Device

Type of 510(k): Traditional Common Name: Powered muscle stimulator Trade Name: Electronic Pulse Stimulator Model: S3 Classification Name: Transcutaneous electrical nerve stimulator for pain relief Review Panel: Neurology Regulatory Class: II Product Code: NUH, NGX Regulation Number: 21 CFR 882.5890

III. Predicate Device

Applicant	Predicate Device	510(k) Number	Approval Date
PhilipsLifstyle	(Primary):PulseRelief	K151035	July 21,2015
HIVOX BIOTEK INC.	HIVOX OTC ElectricalStimulator /SEM44	K171803	November 29, 2017
ShenzhenOSTOTechnology CompanyLimited	Health Expert ElectronicStimulator, Model AST-300C and AST-300D	K133929	November 12, 2014

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IV. Device Description

V. Indications for Use

Mode 1 (PMS): To be used for stimulating healthy muscles in order to improve and facilitate muscle performance.

Mode 2 (TENS): To be used for temporary relief of pain associate 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.

VI. Comparison of Technological Characteristics With the Predicate Devices

The Electronic Pulse Stimulator is substantially equivalent to the predicate devices based on intended use, design, specifications and performance.

The Electronic Pulse Stimulator raises no safety or efficacy concerns when compared to the following predicate devices.

Information for predicate device was obtained from publicly available sources, including the 510(k) Summary and device instruction manual. A technical comparison to the predicate is provided below:

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Comparison Elements	Subiect Device	(Primary) Predicate Device K151035	Predicate Device K171803	Predicate Device K133929	Comparison
Trade Name/Model	Electronic Stimulator/S3	PulseRelief	HIVOX OTC Electrical Stimulator/SEM44	Health Expert Electronic Stimulator, Model AST-/300C and AST-300D	/
510(k) Number	To be assigned	K151035	K171803	K133929	/
Manufacturer	Shenzhen Leading Perfection Technology Co., Ltd	Philips Lifsty	HIVOX BIOTEK INC.	Shenzhen OSTO Technology Company Limited	/
Regulation Number	21CFR 882.5890	21CFR 882.5890 and 890.5850	21CFR 882.5890	21 CFR 882.5890	SE
Device Class	II	II	II	II	SE
Product Code	NUH, NGX	NUH, NGX	NUH, NGX	NUH, NGX	SE NOTE 1
Indication for Use/Intended Use	Mode 1(PMS): To be used for stimulating healthy muscles in order to improve and facilitate muscle performance.Mode 2(TENS): To be used for temporary relief of pain associate with sore and aching muscles in the shoulder, waist, back, neck, upper extremities(arm) and	The OTC TENS/EMS stimulator PulseRelief 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	SEM44 (EMS): The device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.SEM44 (TENS): The device is designed to be used for temporary relief	PMS (Mode 1~~8) It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.TENS (Mode 9~~25) To be used for temporary relief of pain associated with sore and aching muscles in	SE NOTE 1
extremities (leg),abdomen and bottomdue to strain fromexercise or normalhousehold workactivities
ComparisonElements	Subject Device	(Primary) PredicateDevice K151035	Predicate DeviceK171803	Predicate DeviceK133929	Comparison
		lower extremities (leg)due to strain fromexercise or normalhousehold workactivities.It should be applied tonormal, healthy, dryand clean skin of adultpatients, and is to beused for stimulatehealthy muscles inorder to improve andfacilitate muscleperformance.	of pain associated withsore and aching musclesin the shoulder, waist,back, neck, upperextremities (arm), lowerextremities (leg),abdomen and bottom dueto strain from exercise ornormal household workactivities.	the shoulder, waist, back,back of the neck, arm, leg,and foot due to strain fromexercise or normal householdwork activities by applyingcurrent to stimulate nerve.
Shape of electrodes	Rectangle	Square	Unknown	Rectangle	SE
Anatomical application	Arm, leg, abdomen,hip, feet	Shoulder, waist, back,upper extremities(arm), and lowerextremities (leg)	Shoulder, waist, back,neck, upper extremities(arm), lower extremities(leg), abdomen andbottom	Shoulder, waist, back, backof the neck, arm, leg, andfoot	SE
Applicable People	Adults	Adults	Adults	Adults	SE
Location for Use	OTC	OTC	OTC	OTC	SE
Basic Unit Characteristics
ComparisonElements	Subiect Device	(Primary)Predicate DeviceK151035	Predicate DeviceK171803	Predicate DeviceK133929	Comparison
Power Supply	USB rechargeablebattery, 3.7V	Li-ion 3.7V 500mAH	4.5V (batteries, 3×1.5V AAA)	Adaptor Input: 100-240Vac, 50-60Hz, 0.1AOutput: 5Vdc, 1AUnit Input: 5Vdc, 1A	SENOTE 2
Method of LineCurrent Isolation	N/A	N/A	N/A	Type BF Applied Part	SE
PatientLeakageCurrent	< 0.1	<10μA	N/A	AC: 54.5μA, DC: 0.5μA	SE
Signal FaultCurrentCondition	N/A	<50μA	N/A	AC:120.0μA,DC: 0.6μA	SE
Number of OutputModes	2 (1 TENS and 1 EMS)	EMS: 5TENS:15	EMS: 35TENS:15	EMS: 8TENS:17	SENOTE 2
Number of OutputChannels	1	1	2	2	SENOTE 2
Synchronous orAlternating?	N/A	N/A	Synchronous	Synchronous	SE
Method of ChannelIsolation	N/A	N/A	By electrical circuit andsoftware	Voltage TransformIsolation"BODY▼" and" BODY▼" buttons forbody channel," SOLE ▲" and"SOLE▼" buttons forfeet channel	SE
ComparisonElements	Subiect Device	(Primary) PredicateDevice K151035	Predicate DeviceK171803	Predicate DeviceK133929	Comparison
Software /Firmware/MicroprocessorControl?	Yes	Yes	Yes	Yes	SE
	Automatic OverloadTrip?	Yes	Yes	Yes	No	SE
Yes		Yes	Yes	No	SE
Automatic No-LoadTrip?		Yes	Yes	Yes	No	SE
Automatic Shut OFF?		Yes	Yes	Yes	Yes	SE
Patient OverrideControl?		Yes	Yes	Yes	Yes	SE
IndicatorDisplay	On/OffStatus?	Yes	Yes	Yes	Yes	SE
	LowBattery?	Yes	Yes	Yes	No	SE
	Voltage/CurrentLevel?	No	Yes	Yes	Yes	SE
Timer Range		25 minutes	1~59minutes andcontinuous	5~100minutes	25 minutes	SENOTE 2
CompliancewithVoluntary Standards?		IEC60601-1-2IEC60601-1IEC60601-11	IEC60601-1-2IEC60601-1IEC60601-2-10	IEC60601-1-2IEC60601-1IEC60601-2-10	IEC60601-1-2IEC60601-1IEC60601-2-10	SE
ComparisonElements		Subiect Device	(Primary)PredicateDevice K151035	Predicate DeviceK171803	Predicate DeviceK133929	Comparison
		IEC60601-2-10ISO10993-5/10	ISO10993-5/10	ISO10993-5/10	ISO10993-5/10
Compliancewith21CFR898		Yes	Yes	Yes	Yes	SE
Weight		14.5g(with battery)	62g (excl. electrodes)	89g (including belt clip,without batteries)123g (including belt clip,and batteries)	2Kg (Without accessories)	SENOTE 3
Dimensions		Ф4.2cm×1.38cm	54×54×14mm (unit)	132 x 63 x29.5mm(includingclip)	428mm x 428.8mm x185mm	SENOTE 3
Housing Materials andConstruction(Mainunit)		ABS	ABS, PC	ABS	ABS	SE
Output Specifications
Waveform		Symmetricalrectangular	Biphasic, rectangular	Biphasic, square	Pulsed, symmetric,Biphasic, Rectangular,	SENOTE 4
MaximumOutput	$@500Ω$	40±20%	31±20%	100±10 % (50±10 %(Vp))	44±10%	SENOTE 4
Voltage(Volts,	$@2kΩ$	64±20%	69±20%	180±10 % (90±10 %(Vp))	80±10%	SENOTE 4
ComparisonElements		Subject Device	(Primary)PredicateDevice K151035	Predicate DeviceK171803	Predicate DeviceK133929	Comparison
Vp)	@10kΩ	76±20%	70±20%	250±10 % (125±10 %(Vp))	112±10%	SENOTE 4
MaximumOutputCurrent(mA)	@500Ω	80±20%	62±20%	200±10 % (100±10 %(Ip))	88±10%	SENOTE 4
	@2kΩ	32±20%	34±20%	90±10 % (45±10 %(Ip))	40±10%	SENOTE 4
	@10kΩ	7.6±20%	7±20%	25±10 % (12.5±10 %(Ip))	11.2±10%	SENOTE 4
Pulse Width		200μs	TENS: 60~~350μsEMS: 150~~350μs	50-450μs	120μs	SENOTE 4
Frequency (Hz)		Mode 1: 4-35HzMode 2: 4-41Hz	TENS: 1~~100HzEMS: 45~~65Hz	1-150Hz	77.3Hz	SENOTE 4
MaximumPhaseCharge (μC) @500Ω		22.31	TENS: 1.6~~6.8EMS: 4.7~~10.9	0.045	12.78μC @ 500Ω	SENOTE 4
MaximumDensity@500Ω	Current(mA/cm²)	Hips pad: 0.079Arms and legs pad:0.104Abdomen pad: 0.111Feet pad: 0.016	TENS: 0.002~~0.045EMS: 0.019~~0.037	0.667	0.235mA/cm² @ 500Ω	SENOTE 4
MaximumDensity@500Ω	Power(W/cm²)	Hips pad: 0.0001Arms and legs pad:0.0002Abdomen pad: 0.0002	(average)TENS: 0.24~~1.69EMS: 0.62~~1.15	0.0046	1.38mW/cm² @ 500Ω	SENOTE 4
ComparisonElements	Subject Device	(Primary) PredicateDevice K151035	Predicate DeviceK171803	Predicate DeviceK133929	Comparison
	Feet pad: 0.00003
BurstMode	Pulses perburst	N/A	TENS: 5, 7EMS: N/A	3	--	SE
	Bursts persecond	N/A	TENS: 1, 2, 3EMS: N/A	2/60Hz	--	SE
	Burstduration(seconds)	N/A	TENS: 62.5~87.5EMS: N/A	36ms	--	SE
	Duty Cycle[Line(b) xLine (c)]	N/A	TENS: 6.3%~19%EMS: N/A	36ms/390ms	--	SE
ON Time (seconds)		1s	TENS: N/AEMS:--intensity ramp-up:2~~4sec--constant intensity:5~~6sec--intensity ramp-down:1~2sec	2s	0.6s	SE
OFF Time (seconds)		4s	TENS: N/AEMS: N/A	2s	0.6s	SE

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Comnarison in details:

NOTE 1: The "Intended Use" of the subject device is the substantially equivalent to the predicate devices selected, all have adopted TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscle Stimulation) technologies to the treatment of temporary relief of pain associate with sore and aching muscle performance improvement of healthy muscles respectively. Meanwhile, the

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"Product Code" of the subject device is the same as the predicate devices. This define does not affect the intended use of the subject device.

NOTE 2: Although the "Power Supply", "Number of Output Channels", and "Timer Range" of the subject device are a little different from the predicate devices, they are all complaint with the requirements of IEC 60601-1 standard. So these differences will not raise any safety or effectiveness issue.

NOTE 3: Although the "Weight" and "Dimensions" of the subject device are different from the predicate devices are insignificant in the terms of safety or effectiveness.

NOTE 4: Although the "Waveform", "Maximum Output Current", "Pulse Duration", "Frequency", "Maximum Phase Charge", "Maximum Current Density", and "Maximum Power Density" of the subject device are a little different from the predicate devices, they all comply with the requirements of IEC 60601-1 and IEC 60601-2-10 standard, as well as the Guidance for Powered Muscle Stimulator for Muscle Conditioning. So these differences will not raise any safety or effectiveness issue.

CONCLUSION: The subject device Electronic Pulse Stimulator is substantially equivalent to the predicate devices.

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VII.Performance Data

The following performance data were provided in support of the substantial equivalence determination.

1) Biocomnatibility Testing

The direct components of applied parts contacting with the users in the Electronic Pulse Stimulator is as the following item:

Component Name	Material of Component	Body Contact Category	Contact Duration
Electrode pads used for hips, arms and legs, and abdomen (hips pad, arms and legs pad, and abdomen pad)	Conductive hydrogel	Surface-contacting skin	Max. 25 minutes, less than 24 hours
Electrode pads used for feet (feet pad)	PU fabric (contained sliver paste and conductive oil)	Surface-contacting skin	Max. 25 minutes, less than 24 hours

The electrode pads are directly purchased from qualified supplier which has been tested and passed the In Vitro Cytotoxicity, Skin Sensitization test in accordance with the ISO10993-1 standards. So we have reason to believe that the electrode pads are safe for the users. For details, please refer to "Biocompatibility Discussion" in this application.

2) Electrical and EMC Safety

Electrical safety and EMC safety testing was performed to, and passed, the following standards:

IEC 60601-1 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
IEC 60601-1-11 Medical electrical equipment -Part 1-11: General requirements for basic safety and essential performance -Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
IEC 60601-2-10 Medical electrical equipment -- Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
IEC 60601-1-2 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility -Requirements and tests

In addition to the compliance of voluntary standards:

The software verification has been carries out according to the FDA Guidance for the Content of Premarket Submission for Software Contained in Medical Devices.
The waveform test report has also been conducted to verify the output specifications of the subject device according to the FDA Guidance for Powered Muscle Stimulator 510(k)s
The adhesion test report has been conducted to verify the maximum duration of use for the electrodes used by the subject device according to the requirements of AAMI EC 12_2000(R) 2010-Section 5.4.

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The dispersion and shelf life test report has been conducted to verify the current dispersion and shelf-life of the electrodes used by the subject device in the expiration date according to the requirements of the FDA guidance –Shelf Life of Medical Device and ASTM F 1980-07 standard.

Summary

Based on the above performance as documented in this application, Electronic Pulse Stimulator was found to have a safety and effectiveness profile that is similar to the predicate devices.

VIII. Conclusions

The subject device Electronic Pulse Stimulator is to be concluded substantial equivalent to its 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).