TENS function of the device is indicated for the following use: Symptomatic relief and management of chronic (long-term), intractable pain and an adjunctive treatment in the management of post-surgical pain and post-traumatic acute pain NMES function of the device is indicated for the following use: - Relaxation of muscle spasms - Prevention or retardation of disuse atrophy Increasing local blood circulation - Muscle re-education - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis - Maintaining or increasing range of motion

Device Description

The OGYILI TENS/NMES Stimulator E01 is a 2 channel TENS/NMES stimulator device that is used to help reduce pain, with each channel being isolated from the other. The OGYILI TENS/NMES Stimulator is a programmable device that come equipped with 14 preset programs along with 14 user programs. The user programs are adjustable and can be changed to best help the patient at the doctor's recommendation and prescription settings. The program modes are preset programs that a clinician can conveniently choose from should they desire. This device has a special masking program to make the unwanted programs unavailable to the patients while locking the device in the needed relief setting. This way the patient does not receive the knowledge or ability to change the doctor's prescription settings without a clinician's consent. The OGYILI TENS/NMES Stimulator is programmed to default to program P- 14 which contains the most common setting. The device gives the clinician ability to store frequencies or to choose from a set of many frequencies that allow quick and easy selection, for prescription of stimulation regimen that can be later stored in any of the many available memory slots. However once the program is set the patients does not have the ability to alter the program from what the doctor or licensed practitioner has deemed to be the most appropriate program for their patient's needs. The OGYILI TENS/NMES Stimulator has the following specifications: There is pulse mode with a bi-phase rectangular pulse frequency is 2Hz to 150Hz, the pulse width is 100-200 us. The power supply is DC 3.7-volt lithium battery. OGYILI TENS/NMES Stimulator package is comprised of the following items: - One TENS/NMES unit powered by DC 3.7-volt lithium battery ● - Two UL industry standard wires for electrodes conforming to FDA standards, ● - Four standard commercially available round 100 (mm) self adhesive electrodes. - One UL 110 battery rechargeable unit - Instruction manual. ● - Quick start instruction manual. ● - . Full package carrying case. The device has physical dimensions of 92 x 60 x 18 mm, and weighs 90 grams with battery.

AI/ML Overview

The provided document describes the OGYILI TENS/NMES Stimulator and its substantial equivalence to predicate devices, rather than an acceptance criteria study for a novel device. Therefore, the information requested regarding a new device's acceptance criteria, study details, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set, and ground truth establishment is not present in this document.

However, I can extract the performance standards and compliance for the OGYILI TENS/NMES Stimulator, which serve as evidence that the device meets certain technical acceptance criteria. These are derived from comparisons to legally marketed predicate devices.

Here's the relevant information based on the provided text, structured to best fit your request:

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

For the OGYILI TENS/NMES Stimulator, the "acceptance criteria" appear to be compliance with relevant IEC and ISO standards and having performance characteristics that are "similar" or "within the range covered by the predicate device." The reported device performance is its demonstrated compliance with these standards and its measured output parameters.

Acceptance Criteria (Standard Compliance & Performance Similarity to Predicate)	Reported Device Performance (OGYILI TENS/NMES Stimulator)	Remarks (Comparison to Predicate)
Biocompatibility: Complies with ISO 10993-1	Biocompatible per ISO 10993-1	Substantially Equivalent (SE)
Electrical Safety: Complies with IEC 60601-1	Tested to demonstrate compliance with IEC 60601-1	SE
Electromagnetic Compatibility (EMC): Complies with IEC 60601-1-2	Tested to demonstrate compliance with IEC 60601-1-2	SE
Performance Standards (Nerve and Muscle Stimulators): Complies with IEC 60601-2-10	Tested to demonstrate compliance with IEC 60601-2-10	SE
Usability Standards: Complies with IEC 60601-1-6	(Mentioned as a standard conformed to, but no specific test results on usability presented)	Not explicitly compared in Table 5.4, but listed as conformed to.
Biological Evaluation: Complies with ISO 10993-1	(Mentioned as a standard conformed to, and in Table 5.4)	SE
Output Pulse Shape: Rectangular, similar to predicate devices	Rectangular	SE
Maximum Output Voltage: Within range of predicate devices	17-20v +/-20%@ 500kΩ48-60v +/-20%@ 2KΩ95-125v +/-20%@ 10KΩ	SE (output parameters are either within range or in close proximity to predicate devices)
Maximum Output Current: Within range of predicate devices	36-40mA +/-20%@ 500Ω24-30mA +/-20%@ 2KΩ9-12.5mA +/-20%@ 10KΩ	SE (output parameters are either within range or in close proximity to predicate devices)
Pulse Duration: Within range of predicate devices	100-200 μS @ 500Ω	SE (within range or in close proximity to predicate devices)
Frequency: Within range of predicate devices	2-150 Hz	SE (within range or in close proximity to predicate devices)
Net Charge per Pulse: Within range of predicate devices	12-21 [μC] @ 500Ω	SE (within range or in close proximity to predicate devices)
Maximum Phase Charge: Within range of predicate devices	12-21 [μC] @ 500Ω	SE (within range or in close proximity to predicate devices)
Maximum Current Density: Within range of predicate devices	0.16-0.54mA/cm2@500Ω	SE (within range or in close proximity to predicate devices)
Maximum Average Power Density: Within range of predicate devices	0.0002-0.0026mA/cm2@500Ω	SE (within range or in close proximity to predicate devices)
Burst Mode: Functional parameters within range of predicate devices	Pulses per Burst: 9Bursts per Second: 2Burst duration: 175 μs – 5sON Time: 5-8 secondsOFF time: 5-12 seconds	SE (functional parameters within range or in close proximity to predicate devices)
Average DC current through electrodes (device on, no pulses): User pure AC, no DC current used	User pure AC, No DC current used	SE
Method of current isolation: Individually isolated circuits, and transistors	Individually isolated circuits, and transistors	SE
Regulated Output: Regulated Voltage (similar to one predicate)	Regulated Voltage	SE

2. Sample size used for the test set and the data provenance
The document does not detail a "test set" in the context of human data or AI evaluation. The study described is a device comparison and performance testing against standards. The performance testing involves bench tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The study is not an AI/clinical performance study requiring expert ground truth for interpretation.

4. Adjudication method for the test set
Not applicable. The study is not an AI/clinical performance 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 is not an AI-assisted diagnostic device; it is a TENS/NMES stimulator.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve an algorithm for diagnostic or assistive performance in the way described. The "performance testing" referenced is for the device's electrical and mechanical output according to industry standards.

7. The type of ground truth used
The "ground truth" for this device's performance is established by compliance with recognized international standards (IEC, ISO) and the measured physical and electrical output characteristics which are then compared to legally marketed predicate devices.

8. The sample size for the training set
Not applicable. This device is not an AI/machine learning model and therefore does not have a "training set."

9. How the ground truth for the training set was established
Not applicable. No training set is involved.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of 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 a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 9, 2020

Gongguan Tutamen Metalwork Co., LTD % Charles Shen Official Correspondent Manton Business and Technology Services 37 Winding Ridge Oakland, New Jersey 07436

Re: K201431

Trade/Device Name: OGYILI TENS/NMES Stimulator Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: GZJ, IPF Dated: August 11, 2020 Received: August 13, 2020

Dear Charles Shen:

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/cfpmr/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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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.

Heather Dean, PhD Assistant Director, Acute Injury Devices Team 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

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Indications for Use

510(k) Number (if known) K201431

Device Name

OGYILI TENS/NMES Stimulator

Indications for Use (Describe)

TENS function of the device is indicated for the following use:

Symptomatic relief and management of chronic (long-term), intractable pain and an adjunctive treatment in the management of post-surgical pain and post-traumatic acute pain

NMES function of the device is indicated for the following use:

· Relaxation of muscle spasms
· Prevention or retardation of disuse atrophy
Increasing local blood circulation
· Muscle re-education
· Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
· Maintaining or increasing range of motion

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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510(k) Summary:

This summary of 510k safety and effectiveness information is being submitted In accordance with the requirements of 21CFR 807.92

5.1 Submitter & Foreign Manufacture Identification

Dongguan Tutamen Metalwork Co., LTD.

No.2, HuangGuoTang Rd, Shahu, Tangxia Town Dongguan, Guangdong Province, 523001 CHINA Tel: (086) 769 87989845 Submitter's FDA Registration Number: N/A

5.2 Contact Person

Charles Shen Manton Business and Technology Services 37 Winding Rdg, Oakland, NJ 07436 Tel: 608-217-9358 Email: cyshen@aol.com

5.3 Date of Summary: November 02, 2020

5.4 Device Name:

Proprietary Name:	OGYILI TENS/NMES Stimulator
Device Common Name:	TENS/NMES Stimulator
Classification Regulation:	21 CFR882.5890
Class:	Class 2
Panel:	Neurology
Product Code:	GZJ
Subsequent Product Code:	IPF
Prior FDA correspondence:	None

ર્સ્ટ Predicate Device Information:

The "OGYILI TENS/NMES Stimulator E01" described in this premarket notification is substantially equivalent to:

K193275. "Nerve and Muscle Stimulator (model: XFT-2000)", Manufactured by (1) "Shenzhen XFT Medical Limited"
Reference Device:
(2) K092990, "AMD 6605" manufactured by "Shenzhen Dongdixin Technology Co., Ltd.''

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K162517, "Electronic Pulse Stimulator", Manufactured by "JKH Health Co., (3) Ltd."

Device Description: ર્સ્વ

The device gives the clinician ability to store frequencies or to choose from a set of many frequencies that allow quick and easy selection, for prescription of stimulation regimen that can be later stored in any of the many available memory slots. However once the program is set the patients does not have the ability to alter the program from what the doctor or licensed practitioner has deemed to be the most appropriate program for their patient's needs.

The OGYILI TENS/NMES Stimulator has the following specifications: There is pulse mode with a bi-phase rectangular pulse frequency is 2Hz to 150Hz, the pulse width is 100-200 us. The power supply is DC 3.7-volt lithium battery.

OGYILI TENS/NMES Stimulator package is comprised of the following items:

One TENS/NMES unit powered by DC 3.7-volt lithium battery ●
Two UL industry standard wires for electrodes conforming to FDA standards, ●
Four standard commercially available round 100 (mm) self adhesive electrodes.
One UL 110 battery rechargeable unit
Instruction manual. ●
Quick start instruction manual. ●
. Full package carrying case.

The device has physical dimensions of 92 x 60 x 18 mm, and weighs 90 grams with battery.

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5.7 Indications for Use:

TENS function of the device is indicated for the following use:

Symptomatic relief and management of chronic (long-term). intractable pain and an adjunctive treatment in the management of post-surgical pain and post-traumatic acute pain

NMES function of the device is indicated for the following use:

Relaxation of muscle spasms
Prevention or retardation of disuse atrophy ●
Increasing local blood circulation
Muscle re-education
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis ●
Maintaining or increasing range of motion ●

5.8 Performance Testing Summary:

Design control activities for this modification were performed and bench tests have been done. Those performance tests, risk management, and design verification tests provide demonstration that the device does not raise any new questions of safety and effectiveness.

The subject device conforms to the following standards:

IEC 60601-2-10, Particular requirements for the basic safety and essential ● performance of nerve and muscle stimulators
IEC 60601-1-6, General Requirements For Basic Safety And Essential ● Performance - Collateral Standard: Usability
IEC60601-1, Electrical safety; ●
IEC60601-1-2, Electromagnetic compatibility ●
ISO 10993-1, Biological evaluation of medical devices -- Part 1: Evaluation and ● testing within a risk management process

Technological Comparison with Predicate Device 5.9

Table 5.1 below shows similarities and differences of use, mechanism, and labeling between our device and the predicate devices.

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Table 5.1: Comparison of Intended Use, Mechanism, and Labeling

Description	Subject Device	Primary Predicate Device(K193275)	Reference Device (K092990)	Remark
Product Code	GZJ	GZJ	GZJ	SE
RegulationNumber	21 CFR882.5890	21 CFR882.5890	21 CFR882.5890	SE
Indication ForUse	TENS function of the device isindicated for the following use:Symptomatic relief andmanagement of chronic (long-term), intractable pain and anadjunctive treatment in themanagement of post-surgicalpain and post-traumatic acutepainNMES function of the device isindicated for the following use:Relaxation of muscle spasms Prevention or retardation of disuse atrophy Increasing local blood circulation Muscle re-education Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis Maintaining or increasing range of motion	Over-The-Counter Use:TENS[ (Program 19,Program 15 (Frequency<5Hzor >15Hz)]: XFT-2000 isused for temporary relief ofpain associated with sore andaching muscles due to strainfrom exercise or normalhousehold and work activities.XFT-2000 is also intended forthe symptomatic relief andmanagement of chronic,intractable pain and relief ofpain associated with arthritis.NMES[ (Program 1014,Program15(5Hz≤Frequency≤50Hz)]:XFT-2000 is used to stimulatehealthy muscles in order toimprove and facilitate muscleperformance. To be used forthe improvement of muscletone and firmness, and forstrengthening muscles in thearms, abdomen, legs, andbuttocks. Not intended for usein any therapy or for thetreatment of any medicalconditions or diseases.Prescription Use:XFT-2000 is intended for thefollowing use:- Relaxation of muscle spasms- Prevention or retardation of disuse atrophy- Increasing local blood circulation- Muscle re-education- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis- Maintaining or increasing range of motion	TENS function of the device isindicated for the followinguse:Symptomatic relief andmanagement of chronic (long-term), intractable pain and anadjunctive treatment in themanagement of post-surgicalpain and post-traumatic acutepainNMES function of the deviceis indicated for the followinguse:Relaxation of muscle spasms Prevention or retardation of disuse atrophy Increasing local blood circulation Muscle re-education Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis Maintaining or increasing range of motion	SE
		- Adjunctive treatment in themanagement of post-surgicaland post-traumatic acute pain
TargetPopulation	18 years and older	Adult Population	18 years and older	SE
Components	Control unit and electrode	Control unit and electrode	Control unit and electrode	SE
Contradictions	Never use your TENS/NMESon:Atrophied muscles.Muscles with spasms.Muscles associated with animpaired joint or limb.Muscles with undiagnosed pain.Never use the TENS/NMESwhen pregnant or if you thinkyou are pregnant.Do not use your TENS/NMESWith cardiac pacemakers,defibrillators, or other implantedmetallic or electronic devices.Over or around the neck/carotidsinus.Over the neck, mouth or face.Over the carotid sinus nerves.Trans cerebrally (over the head).Over/around the eyes.Over the heart or chest.When there is a possibility tohaemorrhage following acutetrauma or fracture.After surgical procedures whenmuscle contraction may affect thehealing process.On areas of skin which lacknormal sensation	Not available as publicinformation	Patients with pacemakers andheart conditions Patients withpacemakers and heartconditions TENS/NMES:should NOT use - should NOTuse Do NOT use stimulationover the carotids Do NOT usestimulation over the carotidssinus nerves, the larynx orthroat muscles sinus nerves,the larynx or throat musclesDo NOT use stimulation trans-cerebrally. Do NOT usestimulation trans-cerebrally.Do NOT use on undiagnosedpain or until Do NOT use onundiagnosed pain or until Ietiology is established.	Similar
Characteristic	Subject device (K201431)	Primary Predictive Device (K193275)	Reference Device (K092990)	Reference Device (K162517)	Remarks
Unit Name:	OGYILI TENS/NMES UNIT	XFT - 2000	AMD 6605	PL-029K12
Manufacturer	Tutamen Metal Co., LTD	Shenzhen XFT Medical Limited	Shenzhen Dongdixin Technology Co., Ltd.	JKH USA LLC
Power source	Use a Lithium-ion battery	DC4.5V, 3xAAA batteries; DC adaptor	Battery	Rechargeable or non-rechargeable battery	SE
a. Method of Line Current isolation	N/A battery operated	N/A battery operated	N/A battery operated	N/A battery Operated	SE
b. Patient Leakage current	N/A battery operated	N/A battery operated	N/A battery operated	N/A battery operated	SE
a. Normal condition	N/A battery operated	N/A battery operated	N/A battery operated	N/A battery operated	SE
b. Single Fault Condition	N/A battery operated	N/A battery operated	N/A battery operated	N/A battery operated	SE
Average DC current through electrodes when device is on but no pulses are being applied	User pure AC, No DC current used	User pure AC, No DC current used	User pure AC, No DC current used	User pure AC, No DC current used	SE
Number of output modes	14 programs	15 programs	Information not available	8 programs	Similar
Output channels	2 output Channels	2 output channels	2 output channels	1 output channel	SE
a. Method of current isolation	Individually isolated circuits, and transistors	Individually isolated circuits, and transistors	Individually isolated circuits, and transistors	NA	SE
Regulated Current or Regulated Voltage?	Regulated Voltage	Regulated Current	Information not available	Regulated voltage	SE

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The subject device are predicate devices are essentially identical in terms of use, and mechanism. They have minor different wording in the descriptions of contradictions, but the actual contents are very similar.

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Table 5.2 shows similarities and differences of mechanism and design between our device and the predicate devices.

Table 5.2: Comparison of Mechanism and Design

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Indicator Display:			Shows On/Off Status	Shows On/Off Status	SE
On/OFF Status?	Yes, Shows On/off status	Shows On/Off Status		Yes shows battery low
Low Battery?	Yes, Shows Low Battery	Yes shows battery low		Shows voltage level
Voltage/Current Level?	Yes, shows output level 1-15(1 being low 15 being high)	Shows voltage level
Software
firmware, microprocessorcontrol	MCU: PIC16F1937 EditionV1.0	MCU	MCU	MCU	SE
Automatic overload trip	Yes	Yes	NO, Battery operated	NO
Automatic No load trip	Yes	Yes	NO, Battery Operated	Yes
Automatic Shut Off	Yes	Yes	Yes	Yes
User Override control	Yes, pause button	Yes, pause button	Yes (anytime)	Yes, pause button
Timer Range (minutes)	15min - 60min	60min	15min - 60min	10- 540min
Hardware and materials
Housing constructionmaterial	ABS	ABS	ABS	ABS	SE
Size:	92 x 60 x 18mm	108 x 62 x 26mm	141 (L) x 60(W) X18(H) mm	n/a
Weight:	0.07 kg. without battery,0.09kg. with battery	96g with battery	115 grams	25g
Electrode Lead wires
Length	1.m		2' round self-adhering		SE
Construction	Strand		reusable Amgel based
Materials	Copper wire PVC Coating		electrodes, FDA
Electrode connectors	2x2mm Pin connector		approved
510K number:	K171722	K132588

The subject device is essentially identical to the predicate device in terms mechanism and design. The differences in number of programs, dimension and weight does not raise safety and effectiveness issues. The electrode leas wire is FDA 510(K) cleared, as the predicate devices.

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Table 5.3 shows similarities and differences of output performance between our device and the predicate devices.

Characteristic	Subject device (K201431)	Primary Predictive Device(K193275)	Reference Device (K162517)	Remarks
Shape	Rectangular	Rectangular	Rectangular	SE
Maximum OutputVoltage (V) (+/-___%)	17-20v +/-20%@ 500kΩ	29.7-39v +/-20%@ 500kΩ	29.6-57.6v +/-20%@ 500kΩ	SE
	48-60v +/-20%@ 2KΩ	89.1-90.6v +/-20%@ 2KΩ	80.8-86.4v +/-20%@ 2KΩ
	95-125v +/-20%@ 10KΩ	123-125v +/-20%@ 10KΩ	108-134v +/-20%@ 10KΩ
Maximum OutputCurrent (mA) (+/-___%)	36-40mA +/-20%@ 500Ω	59-60mA +/-20%@ 500Ω	59.2-115.2mA +/-20%@ 500Ω	SE
	24-30mA +/-20%@ 2KΩ	44-45.3mA+/-20% @ 2KΩ	33.2-48mA+/-20% @ 2KΩ
	9-12.5mA +/-20%@ 10KΩ	12.3-12.5mA +/-20%@ 10KΩ	10.8-13.4mA +/-20%@ 10KΩ
Pulse duration† (us)	100-200 μS @ 500Ω	150-350 μS 500Ω	100 μS	SE
Frequency (Hz) {or Rate(pps)}	2-150 Hz	2-125 Hz	1.9-104.1 Hz	SE
Net Charge(microcoulombs (μC) perpulse)	12-21 [μC] @ 500Ω	5.9-21 [μC] @ 500Ω	11.8-23 [μC] @ 500Ω	SE
Maximum Phase Charge(μC)	12-21 [μC] @ 500Ω	5.9-21 [μC] @ 500Ω	11.8-23 [μC] @ 500Ω	SE
Maximum Currentdensity ††(mA/cm2,r.m.s.)	0.16-0.54mA/cm2@500Ω	0.15-0.72mA/cm2@500Ω	1.64-3.26mA/cm2@500Ω	SE
Maximum AveragePower Density††(W/cm2)	0.0002-0.0026mA/cm2@500Ω	0.0002-0.0045mA/cm2@500Ω	0.00004-0.00101mA/cm2@500Ω	SE
Burst Mode	Yes/No	Yes/No	n/a
Pulses per Burst	9	15-840	n/a	SE
Bursts per Second	2	0.07-0.33	n/a	SE
Burst duration (seconds)	175 μs – 5s	3-14	n/a	SE
ON Time (seconds)	5-8	3-14	3.4-20	SE
OFF time (seconds)	5-12	2-10	1-2.5	SE

Table 5.3: Comparison of Output Performance

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The output performances of the subject device are either within the range covered by the predicate device, or in the close proximity of the range covered by the predicate device. The subject device essentially has the same performance as that of the predicate device. Our device is essentially identical to the predicate device in terms of indications for use, design, and mechanism, between subject device and the predicate device.

The following table shows similarities and differences of the key performance between the subject device and the predicate devices. Tests were conducted following applicable procedures outlined in the internal procedures and FDA recognized consensus standards, and results met all relevant requirements in the test standards, and are comparable to the predicate device in performance.

Description	Subject Device	Primary PredicateDevice (K193275)	Reference Device(K092990)	Comparison
Biocompatibility	Biocompatible per ISO10993-1	Biocompatible per ISO10993-1	Biocompatible per ISO10993-1	SE
Electric Safety	The proposed device wastested to demonstratecompliance with IEC60601-1	Compliance with IEC60601-1	Compliance with IEC60601-1	SE
EMC	The proposed device wastested to demonstratecompliance with IEC60601-1-2	Compliance with IEC60601-1-2	Compliance with IEC60601-1-2	SE
PerformanceStandards	The proposed device wastested to demonstratecompliance with IEC60601-2-10	Compliance with IEC60601-2-10	Compliance with IEC60601-2-10	SE

Table 5.4: Comparison of Device Performance

The above table shows that the performance is either same or very similar between the subject and predicate device. The subject device is as safe and effective, and its performance meets the requirements of its pre-defined acceptance criteria and intended uses.

5.10 Substantial Equivalence Conclusion

Based on the comparison of intended use. design, and performance, "OGYILI TENS/NMES" manufactured by "Dongguan Tutamen Metalwork Co., LTD." is 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).