To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, back, arm, leg, foot, due to strain from exercise or normal household and work activities.

Device Description

Transcutaneous Electrical Nerve Stimulator is a product that adopts modern electronic science and technology to deliver electric pulses generated to the user's skin through the electrodes.

There are three models of Transcutaneous Electrical Nerve Stimulator which are KTR-206, KTR-208 and KTR-209. Their technical parameters are slightly different, but they share the basically same characteristics: 1) They are small, exquisite and portable; 2) various modes to satisfy different demands, applicable to a wider range of people; 3) wonderful electric pulse combination. 0~16 levels can be adjusted and chosen according to personal preference; 4) LCD display make the operation simple and easy; 5) integrated design of the body is easy for function operation and simple in practical use; 6) battery power display; 7) dual channel output. user can cover more treatment areas. For KTR-208 and KTR-209, the two channels are independently controlled for intensity adjustment which is more convenient to use.

The Transcutaneous Electrical Nerve Stimulator is mainly composed of the host and electrode patches. And it uses AAA batteries for power supply. To start therapy, first insert batteries, then paste the electrode patches onto painful areas and press on/off button to power on. The modes and intensity can be selected according to needs. And the current status is displayed on LCD.

AI/ML Overview

The provided text is a 510(k) Summary for a Transcutaneous Electrical Nerve Stimulator (TENS) device. This document is a premarket submission to the FDA demonstrating that the new device is substantially equivalent to a legally marketed predicate device.

Here's an analysis of the provided text, addressing your specific questions, keeping in mind that a 510(k) typically focuses on substantial equivalence rather than a full clinical trial to establish new clinical efficacy. Therefore, some information, like detailed acceptance criteria from a clinical study or human reader performance, may not be explicitly present as they aren't usually required for a 510(k) for this type of device.

1. Table of Acceptance Criteria and the Reported Device Performance

For a TENS device, acceptance criteria in a 510(k) submission primarily revolve around safety, electrical performance, and substantial equivalence to a predicate device, rather than clinical efficacy metrics (like pain reduction improvement percentage). The document establishes "substantial equivalence" as the primary acceptance criterion.

The table below summarizes the comparison to the predicate device, which serves as the de-facto performance standard for substantial equivalence. The "Acceptance Criteria" are implied by the predicate values and compliance with recognized standards.

Item	Acceptance Criteria (Implied by Predicate/Standards)	Reported Device Performance (Targeted Device)	Outcome
Regulatory Information
Regulation number	21 CFR 882.5890	21 CFR 882.5890	Same
Regulation description	Transcutaneous electrical nerve stimulator for pain relief	Transcutaneous electrical nerve stimulator for pain relief	Same
Product code	NUH	NUH	Same
Class	II	II	Same
Indications for Use	Temporary relief of pain associated with sore or aching muscles	Temporary relief of pain associated with sore and aching muscles in the shoulder, back, arm, leg, foot, due to strain from exercise or normal household and work activities.	Similar
Patient population	Adult	Adult	Same
Location for use	OTC	OTC	Same
Basic Unit Specifications
Leakage current	Compliant with IEC 60601-2-10 (Battery operated: N/A)	N/A (Battery operated)	Same
Software/Firmware/Microprocessor Control?	Yes	Yes	Same
Automatic Overload trip	Yes (Predicate: Yes)	No (Predicate: Yes)	Different
Automatic no-load trip	Yes	Yes	Same
Patient override control method	On/Off button	On/Off button	Similar
Indicator display -On/Off status	Yes	Yes	Same
Indicator display -Low battery	Yes	Yes	Same
Automatic Shut Off	Yes	Yes	Same
Housing material and construction	ABS	ABS	Same
Compliance with voluntary standards	IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-11	IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-11	Similar
Compliance with 21CFR 898	Yes	Yes	Same
Output Specifications
Waveform	Biphasic, Pulsed symmetric, square wave (Predicate is various)	Biphasic, Pulsed symmetric, square wave	Similar
Net Charge (per pulse)	0	0	Same
Maximum Average Current ($500\Omega$)	<50mA (Compliant with IEC 60601-2-10)	KTR-206: 8.04mA; KTR-208: 6.89mA; KTR-209: 12.39mA	Different (but compliant)
Max current density ($500\Omega$)	~0.188-4.8 mA/cm² (Predicate range)	KTR-206: 0.26mA/cm²; KTR-208: 0.22mA/cm²; KTR-209: 0.4mA/cm²	Similar
Max power density ($500\Omega$)	~0.00752-1.38 W/cm² (Predicate range)	KTR-206: 0.001W/cm²; KTR-208: 0.0008W/cm²; KTR-209: 0.0025W/cm²	Similar
Pulse frequency	1-150Hz (Predicate range)	KTR-206: 1 Hz-108Hz; KTR-208: 1 Hz-109Hz; KTR-209: 1 Hz-110Hz	Similar
Pulse duration	50-250μs (Predicate range)	KTR-206: 84μs-134μs; KTR-208: 82μs-128μs; KTR-209: 80μs-224μs	Similar

Notes on Differences and Compliance:

Number of output modes: Targeted device has 5, predicate has 8, reference devices have more. The submission argues this difference doesn't affect safety and effectiveness as the output parameters of each mode were tested and passed relevant IEC standards (Note 1).
Appearance, weight, dimensions: Differ from predicate but are deemed insignificant and do not affect safety and effectiveness (Note 2).
Maximum Average Current: Different from predicate but all targeted device values (8.04mA, 6.89mA, 12.39mA) are < 50mA, complying with IEC 60601-2-10 requirements (Note 3), therefore not affecting safety and effectiveness.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is primarily a non-clinical study involving various tests to demonstrate compliance with recognized electrical safety and performance standards, and comparison of technical characteristics to a legally marketed predicate device. The goal is to establish "Substantial Equivalence (SE)" to the predicate, K140168.

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

Sample Size for Test Set: Not applicable in the context of this 510(k) summary regarding a TENS device. This document describes non-clinical testing of the device itself (electrical parameters, safety, software verification) rather than testing on human subjects for clinical efficacy. There is no "test set" of patient data mentioned for evaluation of diagnostic or therapeutic performance in humans.
Data Provenance: The data provenance is from non-clinical bench testing of the new Transcutaneous Electrical Nerve Stimulator device and comparison of its specifications to the predicate and reference devices. This is not patient data from a specific country or retrospective/prospective study.

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

Not applicable. There is no "ground truth" related to patient outcomes or diagnoses in this 510(k) summary. The "ground truth" for the non-clinical tests would be the specifications and requirements outlined in the referenced standards (e.g., IEC 60601-1, IEC 60601-1-2) which are established by expert consensus in regulatory and technical committees.

4. Adjudication method for the test set

Not applicable. As there is no clinical test set with patient data requiring interpretation or consensus, no adjudication method like 2+1 or 3+1 was used.

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 a TENS device, which directly delivers electrical stimulation for pain relief. It is not an AI-powered diagnostic or assistive technology that human "readers" would use. Therefore, an MRMC comparative effectiveness study involving AI assistance is entirely outside the scope of this device and submission.

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

Not applicable in the sense of an algorithm performance study. The device is a physical TENS unit. Its "standalone" performance is measured by its electrical output characteristics and compliance with safety standards, as detailed in the technical comparison and non-clinical tests.

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

The "ground truth" in this context is established by international consensus standards for medical electrical equipment, particularly those related to TENS devices (e.g., IEC 60601 series). These standards define safety and performance requirements that the device must meet. Additionally, the technical specifications of the predicate device serve as a benchmark for demonstrating substantial equivalence.

8. The sample size for the training set

Not applicable. This device is not an algorithm that requires a "training set" of data.

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

Not applicable. As there is no training set for an algorithm, there is no ground truth established for one.

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which 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.

July 30. 2019

Shenzhen Kentro Medical Electronics Co., Ltd % Tracy Che Registered Engineer Feiying Drug & Medical Consulting Technical Service Group B-3F-3005, Bldg.1, Southward Ruifeng Business Center, No.22 Guimiao Rd. Shenzhen, 518000 Cn

Re: K183288

Trade/Device Name: Transcutaneous Electrical Nerve Stimulator (Models: KTR-206, KTR-208, KTR-209) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH Dated: June 3, 2019 Received: June 5, 2019

Dear Tracy Che:

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.

Pamela Scott Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K183288

Device Name

Transcutaneous Electrical Nerve Stimulator (KTR-206, KTR-208, KTR-209)

Indications for Use (Describe)

To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, back, arm, leg, foot, due to strain from exercise or normal household and work activities.

Type of Use ( Select one or both, as applicable )
----------------------------------------------------------

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510 (k) Summary

This "510(k) Summary" of 510(k) safety and effectiveness information is submitted in accordance with requirements of Title 21, CFR Section 807.92.

(1) Applicant information:

510(k) owner's name:	SHENZHEN KENTRO MEDICAL ELECTRONICS CO., LTD
Address:	No.3, Xihu Industry Zone, Xikeng Village, Henggang Town,
	Longgang District, Shenzhen City, Guangdong Province, China
Contact person:	Zewu Zhang
Phone number:	+86 755 3382 5998
Fax number:	+86 755 3382 5996
Email:	kentro@kentro.com.cn
Date of summary	March 1, 2019
prepared:	prepared:

(2) Proprietary name of the device

Trade name/model:	Transcutaneous Electrical Nerve Stimulator/ KTR-206,KTR-208, KTR-209
Common name:	Stimulator, Nerve, Transcutaneous, Over-The-Counter
Regulation number:	21 CFR 882.5890
Product code:	NUH
Review panel:	Neurology
Regulation class:	Class II

(3) Predicate and reference devices

* Predicate device
Sponsor	Easymed Instruments Co., Ltd
Device Name and Model	EasyStim TN28_OTC
510(k) Number	K140168
Product Code	NUH
Regulation Number	21 CFR 882.5890
Regulation Class	II

彩 Reference device

Sponsor	ShenzhenTechnologyLimited	OSTOCompany	DJO, LLC	Omron Healthcare,Inc.
Device	Name	Health Expert Electronic	Compex® Wireless	Avail, Model

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and Model	Stimulator,AST-300CAST-300D	Model: USAand	PM601
510(k) Number	K133929	K170903	K172079
Product Code	NUH, NGX	NUH, NGX, NYN	NUH, NYN
Regulation Number	21 CFR 882.5890	21 CFR 882.5890	21 CFR 882.5890
Regulation Class	II	II	II

(4) Description/ Design of device:

Transcutaneous Electrical Nerve Stimulator is a product that adopts modern electronic science and technology to deliver electric pulses generated to the user's skin through the electrodes.

(5) Intended use / indications:

To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, back, arm, leg, foot, due to strain from exercise or normal household and work activities.

Component name	Material of Component	Body Contact Category	Contact Duration
Electrode patches	EVA foam, carbon	Surface skin contact	Less than 24 hours

(6) Materials

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film, hydrogel, PET

We have directly purchased the electrode patches from qualified supplier which has obtained FDA clearance with a 510(k) number of K171381 and been legally marketed to US market. For details, please refer to "Biocompatibility Discussion".

(7) Technological characteristics and substantial equivalence:

Item	Targeteddevice	Predicatedevice	Referencedevice 1	Referencedevice 2	Referencedevice 3	Remark
Trade name	Transcutaneous ElectricalNerveStimulator	EasyStimTN28_OTC	Health ExpertElectronicStimulator,Model:AST-300CandAST-300D	Compex®Wireless USA	Avail Model /PM601	/
510(k)number	K183288	K140168	K133929	K170903	K172079	/
Regulationnumber	21 CFR 882.5890	21 CFR 882.5890	21 CFR 882.5890	21 CFR 882.5890	21 CFR882. 5890	Same
Regulationdescription	Transcutaneous electricalnervestimulator forpain relief	Transcutaneous electricalnervestimulator forpain relief	Transcutaneous electricalnervestimulator forpain relief	Transcutaneous electricalnervestimulator forpain relief	TranscutaneousElectricalNerveStimulatorFor PainRelief	Same
Productcode	NUH	NUH	NUH, NGX	NUH,NGX,NYN	NUH, NYN	Same
Class	II	II	II	II	II	Same
Indicationsfor use/Intended use	To be usedfor temporaryrelief of painassociatedwith sore andachingmuscles inthe shoulder,back, arm,leg, foot, dueto strain from	This device isintendedfor the reliefof painassociatedwith sore orachingmuscles ofthe lowerback, arms,or legs due to	TENS (Mode9~25)To be usedfor temporaryrelief of painassociatedwith sore andachingmuscles inthe shoulder,waist, back,	The CompexWireless USATENS is usedfor:• temporaryrelief of painassociatedwith sore andachingmuscles due tostrain from	The Avail isintended forthe relief ofpainassociatedwith sore orachingmuscles ofthe lowerback, arms,legs,	Similar
	normal	exercise or	neck, arm,	normal	or feet due
	household	normal	leg, and foot	household and	to strain
	and work	household	due to strain	work	from
	activities.	and work	from exercise	activities.	exercise or
		activities.	or normal	• the	normal
			household	symptomatic	household
			work	relief and	work
			activities by	management	activities.
			applying	of chronic,	When used
			current to	intractable	for the
			stimulate	pain and relief	symptomati
			nerve.	of pain	c relief and
				associated	managemen
				with arthritis.	t of chronic,
					intractable
					pain and
					relief of
					pain
					associated
					with
					arthritis, use
					the Tap,
					Shoulder,
					Arm or Leg
					mode of
					stimulation.
					Environmen
					ts of Use:
					Clinics,
					hospital and
					home
					environment
					S
					Patient
					Population:
					Adult
Patient	Adult	Adult	Adult	Adult	Adult	Same
population
Location for	OTC	OTC	OTC	OTC	OTC	Same
use
Basic unit specifications
Power	KTR-206:2	2Alkaline	Adaptor	Remote:	Rechargeabl	Similar
supply	AAAbatteries (DC	1.5VAA(LR6)	Input:100-240Vac,	LithiumPolymer	eLithiumion
	3V)	Batteries	50-60Hz, 0.1AOutput:5Vdc, 1AUnit Input: 5Vdc,1A	(LiPo) rechargeable 3.7[V]/≥ 1500[mAhStimulation Modules:Lithium Polymer (LiPo) rechargeable 3.7[V]/ ≥ 450[mAh]	battery
	KTR-208: 2AAAbatteries (DC 3V)KTR-209:AAA LR03battery ×3(DC 4.5V)
Leakagecurrent	N/A (Batteryoperated)	/	AC: 54.5μΑ,DC: 0.5μA(NC)/AC:120.0μA,DC: 0.6μΑ(SFC)	N/A (Batteryoperated)	NormalCondition(uA):<10uASingle FaultCondition(uA):<50uA	Same
Number ofoutputmodes	5	8	25	2	9 TENSmodes;1Microcurrent mode	DifferentNote 1
Number ofoutputchannel	2	2	2	4	1	Same
-Synchronous orAlternating?	KTR-206:SynchronousKTR-208/KTR-209:Alternating	Alternating	Synchronous	Synchronous, but never 2channelsactivated atthe same time.	N/A	Similar
Software/Firmware/Microprocessor Control?	Yes	Yes	Yes	Yes	Yes	Same
AutomaticOverloadtrip	No	Yes	No	Yes	No	Same
Automaticno-load trip	Yes	Yes	No	Yes	Yes	Same
Patientoverride	On/Off button	/	Yes	Yes, push onOn/Off button	Yes, PowerOn/Off	Similar

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controlmethod				directly pausethe program.	button onthe deviceand in theAppsoftware.
Indicatordisplay-On/Offstatus	Yes	Yes	Yes	Yes	Yes on Appand LEDindicator onmain unit.	Same
-Low battery	Yes	Yes	No	Yes	Yes on App
-Outputmode	Yes	Yes	Yes	/	/
-Time tocut-off	Yes	Yes	Yes	/	/
AutomaticShut Off	Yes	Yes	Yes	No	Yes	Same
Timer range	15min defaultKTR-206:5/10/15minKTR-208:5/10/15/20/25/30minKTR-209:5/10/15/20/25/30min	20min,25min,30min,40mindepending onpresetprogram	25min	/	5-60minutesand 30-180minutes	Similar
Dimensions	KTR-206:112.55933.3mmKTR-208:112.55929.5mmKTR-209:129.76017.8mm	66×136×30.7mm	428mm ×428.8mm ×185mm	/	Device:Approx. 60 ×72 ×15.5mm(Both unitshave samedimensions)Charger:Approx. 158 ×90 ×20.5mmPad-L:Approx. 219 ×83.5 ×9.3mm	DifferentNote 2

					Pad-M:Approx. 180× 79.5×9.3mm
Weight	KTR-206:1.68ozKTR-208:1.79ozKTR-209:2.7oz	146.5 grams	70.5oz (2Kg)(Withoutaccessories)	Remote:110[g];StimulationModule:2x60[g];DockingStation 800[g]	Device:Approx. 42g(Both unitshave sameweight)Pad-L:Approx. 21gPad-M:Approx.17.5gCharger:Approx.100g	DifferentNote 2
Housingmaterial andconstruction	ABS	ABS	ABS	/	/	Same
Compliancewithvoluntarystandards	IEC 60601-1,IEC60601-1-2,IEC60601-2-10,IEC60601-1-11.	AAMI/ANSIES60601-1:2005/(R)2012AndA1:2012,IEC60601-1-2,IEC60601-2-10,IEC60601-1-11.	IEC60601-1;IEC60601-1-2;IEC-60601-2-10;ISO10993-5;ISO10993-10	AAMI/ANSIES60601-1:2005/(R)2012And A1:2012,IEC60601-1-2,IEC60601-2-10,IEC60601-1-11.	ES 60601-1,IEC60601-1- 2,IEC60601-2-10,IEC60601-1- 11	Similar
Compliancewith 21CFR898	Yes	Yes	Yes	Yes	N/A	Same
Output specifications
Waveform	Biphasic,Pulsedsymmetric,square wave	Biphasic ,Monophasic,Rectangularwave	Pulsedsymmetric,biphasic,rectangularwithinterphaseinterval	Balanced,asymetricalBiphasic,Rectangularwave	Biphasic ,Rectangularwave	Similar
Maximum	KTR-206:49.6V@ $500\Omega$	68V@500oh	44V±10%@	58V@500ohm	38.4V@500	Similar
outputvoltage	68.5V @ 2kΩ73V @ 10kΩKTR-208:58.5V @ 500Ω70V @ 2kΩ70.5V @ 10kΩKTR-209:62V @ 500Ω80V @ 2kΩ84V @ 10kΩ	ms102V@2kΩms110V@10kΩhms	500Ω80V±10%@2kΩ112V±10%@10kΩ	s170V@2kΩhms180V@10kΩhms	Ω50.8V@2kΩ59.9V@10kΩ
Maximumoutputcurrent	KTR-206:99.2mA @ 500Ω34.25mA @ 2kΩ7.3mA @ 10kΩKTR-208:117mA @ 500Ω35mA @ 2kΩ7.05mA @ 10kΩKTR-209:124mA @ 500Ω40mA @ 2kΩ8.4mA @ 10kΩ	133mA@500Ωhms51mA@2kΩhms11mA@10kΩhms	88mA±10%@ 500Ω40mA±10%@ 2kΩ11.2mA±10%@ 10kΩ	116mA@500Ωohms86mA@2kΩhms18mA@10kΩhms	76.8mA@500Ω25.4mA@2kΩ6.0mA@10kΩ	Similar
Net Charge(per pulse)	0	/	0	0	0	Same
MaximumPhaseCharge(500Ω)	KTR-206:12.32μCKTR-208:18.12μCKTR-209:33.07μC	20.02μC	12.78μC	48μC	7.37μC	Similar
MaximumAverageCurrent(500Ω)	KTR-206:8.04mAKTR-208:6.89mA	3.0375mA	0.968mA	/	0.98mA	DifferentNote 3

	KTR-209:12.39mA
Maximumcurrentdensity(500Ω)	KTR-206:0.26mA/ cm²KTR-208:0.22mA/ cm²KTR-209:0.4mA/ cm²	0.188mA/cm²	0.235mA/cm²	4.8mA/cm²	0.17mA/cm²	Similar
Maximumpowerdensity(500Ω)	KTR-206:0.001W/ cm²KTR-208:0.0008W/cm²KTR-209:0.0025W/cm²	0.00752W/cm²	1.38W/cm²	0.0276W/cm²	0.0006769W/cm²	Similar
Pulsefrequency	KTR-206:1 Hz-108HzKTR-208:1 Hz-109HzKTR-209:1 Hz-110Hz	1-150Hz	77.3Hz	5-122Hz	1-108Hz	Similar
Pulseduration	KTR-206:84μs-134μsKTR-208:82μs-128μsKTR-209:80μs-224μs	50-250μs	120μs	70-300μs	96μs	Similar

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

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

Comparison in details:

Note 1:

Although the number of output is different from that of the predicate, we have tested the output parameters of each mode, and the targeted device has passed IEC 60601-1 and IEC 60601-2-10, so this difference does not affect safety and effectiveness.

Note 2:

Although the appearance, weight and dimensions are different between the targeted and predicate devices, these differences are insignificant and do not affect safety and effectiveness.

Note 3:

Although the maximum average currents are different between the targeted and predicate devices, those are all < 50mA, which comply with the requirements of IEC 60601-2-10 (clause 201.12.4.104), so the difference does not affect safety and effectiveness.

Conclusion:

Transcutaneous Electrical Nerve Stimulator is substantial equivalent to the predicate

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device.

(8) Non-clinical studies and tests performed:

Non-clinical testings have been conducted to verify that the Transcutaneous Electrical Nerve Stimulator meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate device. The testing results demonstrate that the targeted device complies with the following standards:

A IEC 60601-1, Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
A IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-1-11, Medical electrical equipment -- Part 1-11: General requirements for A 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 A for the basic safety and essential performance of nerve and muscle stimulators

The body-contacting components of this device are electrode patches. We have directly purchased the electrode patches from qualified supplier which has obtained FDA clearance with a 510(k) number of K171381 and been marketed to US market. So we have reason to believe that the electrode patches are safe for the users. The electrode patches comply with the following standards.

A ISO 10993-5, Biological Evaluation of Medical Devices -- Part 5: Tests for InVitro Cytotoxicity
A ISO 10993-10, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.

We have also conducted:

A Software verification and validation test according to the requirements of the FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices"
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

(9) Conclusion

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Based on the above analysis and tests performed, it can be concluded that the performance and function of Transcutaneous Electrical Nerve Stimulator are normal, and it is Substantially Equivalent (SE) to the predicate device.

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).