TENS (Mode~20): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.

EMS (Mode 21~~40): It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance. FITNESS (Mode 41~~50): Improvement of abdominal tone, strengthening of the abdominal muscle development of firmer abdomen.

KTR-2241,KTR-2251,KTR-2242,KTR-2252,KTR-2611,KTR-2641,KTR-2612,KTR-2612,KTR-2652: (TENS)

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

Device Description

The Low-frequency Multi-function physiotherapy instrument is a portable and battery powered multifunctional device. The low-frequency multi-function physiotherapy instrument (models: KTR-2240, KTR-2250, KTR-2610, KTR-2640, KTR-2650) offering Transcutaneous Electronic Nerve Stimulator (TENS), Electronic Muscle Stimulation. It has 50 operation modes, which can give certain electrical pulse through electrode pads placed on the skin to help users to enjoy body stimulation. And the TENS (Mode 120) is to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve. EMS (Mode 2140) is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. FITNESS (Mode 41~50) is indicated for the improvement of abdominal muscle tone, for the strengthening of the abdominal muscles and for the development of a firmer abdomen.

The low-frequency multi-function physiotherapy instrument (models: KTR-2241, KTR-2242, KTR-2252, KTR-2611, KTR-2641, KTR-2612, KTR-2612, KTR-2652) offering Transcutaneous Electronic Nerve Stimulator (TENS). It has 15 operation mode, and 6 automatic mode, which can give certain electrical pulse through electrode pads placed on the skin to help users to enjoy body stimulation. The TENS (Mode 1-15) is intended to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.

The electronic stimulatory module has the operating elements of ON/OFF Key, Display screen, Mode Selection key and Intensity Modification keys.

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

The device is equipped with accessories of electrode wires, and batteries. The electrode wire is used to connect the patches to the main unit.

The electrode pads are complying with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization), are interchangeable.

AI/ML Overview

The medical device in question is a "Low-frequency Multi-function physiotherapy instrument" that functions as a Transcutaneous Electrical Nerve Stimulator (TENS), Electrical Muscle Stimulation (EMS), and/or a FITNESS device depending on the model. This is a Class II device.

The provided document describes a 510(k) submission (K200177) where the manufacturer, Shenzhen Kentro Medical Electronics Co., Ltd, aims to demonstrate substantial equivalence to previously cleared predicate devices. The study conducted to prove the device meets acceptance criteria is primarily based on nonclinical (bench) testing and comparison of technical specifications with predicate devices, rather than a clinical trial with human subjects.

Here's the detailed breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are largely implied by compliance with recognized electrical safety and biocompatibility standards, and by demonstrating similar technical specifications to predicate devices. The "reported device performance" is essentially the subject device's specifications and its compliance with stated standards.

Acceptance Criteria (Implied / Standard)	Reported Device Performance (Subject Device K200177)
Electrical Safety	Complies with IEC 60601-1-11 and IEC 60601-2-10 standards.
Electromagnetic Compatibility (EMC)	Complies with IEC 60601-1-2 standard.
Usability	Complies with IEC 62366-1 standard.
Software Verification and Validation	Complies with FDA "Guidance for Pre-Market Submissions and for Software Contained in Medical Devices."
Biocompatibility (for body-contacting parts)	Electrode pads comply with ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization). The electrode patches are purchased from a qualified supplier with FDA clearance (K171381).
Patient Leakage Current	DC: < 0.01µA (reported as NC for Normal Condition, with the value provided in the detailed comparison). While the predicate device reported DC: 0.5µA, the subject device's performance of < 0.01µA is significantly lower and better, satisfying this safety criterion. SFC (Single Fault Condition): 0.1mA (compared to 0.6µA for predicate, the 0.1mA value is acceptable).
Average DC current through electrodes (device ON, no pulses)	< 0.01µA
Number of Output Channels	2 channels.
Number of Output Modes	Models KTR-2240, KTR-2250, KTR-2610, KTR-2640, KTR-2650: 50 modes. Other models (KTR-2241, etc.): 15 modes.
Output Intensity Level	16 steps.
Synchronous or Alternating Channel	Synchronous.
Method of Channel Isolation	Voltage Transform Isolation.
Regulated Current or Voltage	Voltage Control.
Software/Firmware/Microprocessor Control	Yes.
Automatic Overload Trip	No. (Consistent with predicate devices, this is not an acceptance criterion that needs to be "Yes").
Automatic No-Load Trip	No. (Consistent with predicate devices).
Automatic Shut Off	Yes.
User Override Control	Yes.
Indicator Display (On/Off Status, Low Battery, Voltage/Current Level)	Yes (for all listed).
Timer Range	15, 30, 45 min.
Waveform	Pulsed, symmetric, biphasic.
Shape	Rectangular, with interphase interval.
Maximum Output Voltage @ 500Ω (various modes)	Ranges from 20.0V to 46.0V (across different modes). (Within acceptable limits compared to predicates 40-55V). "SE Note 2" indicates these differences do not raise new safety or effectiveness concerns.
Maximum Output Current @ 500Ω (various modes)	Ranges from 40.0mA to 92.0mA (across different modes). (Within acceptable limits compared to predicates 80-110mA). "SE Note 2" indicates these differences do not raise new safety or effectiveness concerns.
Pulse Duration	TENS: 120µs, EMS: 200µs, FITNESS: 200µs.
Pulse Frequency	TENS: (20-100) Hz, EMS: (1-15) Hz, FITNESS: (2-16) Hz.
Net Charge (per pulse) @ 500Ω	0µC, Method: Balanced waveform.
Maximum Phase Charge @ 500Ω (various modes)	Ranges from 5.33µC to 18.40µC. (Within acceptable limits compared to predicates 12.78-19.2µC). "SE Note 2" indicates these differences do not raise new safety or effectiveness concerns.
Maximum Average Current @ 500Ω (various modes)	Ranges from 0.03mA to 3.20mA. (Within acceptable limits compared to predicates 1.53-1.69mA). "SE Note 2" indicates these differences do not raise new safety or effectiveness concerns.
Maximum Average Power Density (various modes)	Ranges from 0.0001 mW/cm² to 0.2044 mW/cm². (Within acceptable limits compared to predicates 0.056-0.08 mW/cm²). "SE Note 2" indicates these differences do not raise new safety or effectiveness concerns.
Maximum Average Current Density (various modes)	Ranges from 0.0010 mA/cm² to 0.1279 mA/cm². (Within acceptable limits compared to predicates 0.064-0.073 mA/cm²). "SE Note 2" indicates these differences do not raise new safety or effectiveness concerns.
ON Time	0.6s.
OFF Time	0.6s.
Environment for Operating	Temp: +5°C-+40°C; Humidity: 15%-93%RH; Atmospheric Pressure: 700hPa-1060hPa.
Environment for Storage	Temp: 0°C-+55°C; Humidity: 0-93%RH; Atmospheric Pressure: 700hPa-1060hPa.

2. Sample Size for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable in the context of a clinical test set. The submission relies on bench testing results, comparing the new device's technical specifications and compliance with standards against predicate devices and in vitro tests for biocompatibility. There is no mention of a patient-based "test set" for performance evaluation.
Data Provenance: The data comes from nonclinical (bench) testing performed by the manufacturer, or through documentation provided by suppliers for components (e.g., electrode pads). The report does not specify the country of origin for these specific tests, but the manufacturer is based in China. The data is retrospective in the sense that it's reported after the tests were conducted, but it's not "retrospective clinical data" as no clinical trials are described.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

Number of Experts: Not applicable. The ground truth, in this context, is established by international standards (IEC, ISO) for electrical safety, EMC, usability, and biocompatibility, as well as FDA guidance for software. These standards themselves are developed by expert consensus within their respective fields, but individual experts are not explicitly cited as establishing ground truth for a discrete test set in this document.
Qualifications of Experts: Not applicable in the context of a clinical test set. The underlying expertise is embedded in the standards and regulatory guidance documents.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. There is no clinical test set requiring expert adjudication. The "adjudication" here is the FDA's review of the submitted technical documentation and its determination of substantial equivalence based on a comparison to recognized standards and predicate devices.

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 a physiotherapy instrument (TENS/EMS/FITNESS), not an AI-powered diagnostic imaging device or a device involving "human readers" or AI assistance in interpretation.

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 generating interpretations or diagnoses that would require standalone performance evaluation. Its "performance" is based on its electrical output characteristics and meeting safety standards.

7. The Type of Ground Truth Used

The "ground truth" used is defined by adherence to international consensus standards for medical device safety and performance (e.g., IEC 60601 series, ISO 10993 series) and technical specifications that fall within the established range of legally marketed predicate devices. For biocompatibility, the ground truth is established by in vitro test results against ISO standards.

8. The Sample Size for the Training Set

Not applicable. This device does not employ machine learning or AI that requires a "training set" of data.

9. How the Ground Truth for the Training Set was Established

Not applicable, as no training set is used.

Summary

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March 25, 2021

Image /page/0/Picture/1 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 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.

Shenzhen Kentro Medical Electronics Co., Ltd % Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. Room 2231, Building 1, Ruifeng center, Kaichuang road, Huangpu district Guangzhou, 51006 Cn

Re: K200177

Trade/Device Name: Low-frequency Multi-function physiotherapy instrument (Model: KTR-2240, KTR-2250, KTR-2241, KTR-2251, KTR-2242, KTR-2252, KTR-2610, KTR-2640, KTR-2650, KTR-2611, KTR-2641, KTR-2651, KTR-2612, KTR-2642, KTR-2652) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX Dated: December 21, 2020 Received: December 28, 2020

Dear Cassie Lee:

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 medical devices and radiation-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 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) K200177

Device Name

Low-frequency Multi-function physiotherapy instrument (Model: KTR-2240, KTR-2250, KTR-2241, KTR-2251, KTR-2252, KTR-2610, KTR-2640, KTR-2650, KTR-2611, KTR-2641, KTR-2651, KTR-2612, KTR-2642, KTR-2652)

Indications for Use (Describe)

KTR-2240,KTR-2250,KTR-2610,KTR-2640,KTR-2650:(TENS, EMS, FITNESS)

TENS (Model~20): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.

KTR-2241,KTR-2251,KTR-2242,KTR-2252,KTR-2611,KTR-2641,KTR-2612,KTR-2612,KTR-2652: (TENS)

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

1. Submitter's Information

510(k) Owner's Name: Shenzhen Kentro Medical Electronics Co., Ltd �
Establishment Registration Number: 3013671142 �
� Address: No. 11, Shanzhuang Road, Xikeng Village, Yuanshan Street, Longgang District, ShenZhen, China
� Tel: +86-755-33825998
Fax: +86-755-33825996 �
� Contact Person: Zewu Zhang (General Manger)
Email: kentro@kentro.com.cn �

2. Application Correspondent:

� Contact Person: Ms. Cassie Lee
Guangzhou GLOMED Biological Technology Co., Ltd. �
Address: 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District, Guangzhou, � Guangdong, China
� Tel: +86 20 8266 2446
Email: regulatory@glomed-info.com �

3. Subject Device Information

Low-frequency Multi-function physiotherapy instrument � Trade Name: Stimulator, Muscle, Powered, For Muscle Conditioning; Common Name: �
Stimulator, Nerve, Transcutaneous, Over-The-Counter
Powered muscle stimulator, Transcutaneous electrical nerve � Classification name: stimulator for pain relief
Neurology, Physical Medicine Review Panel: �
� Product Code: NUH, NGX
Regulation Class: ll �
� Regulation Number: 882.5890, 890.5850

4. Predicate Device Information

Sponsor	Shenzhen Kentro MedicalElectronics Co., Ltd	Guangzhou XinboElectronic Co., Ltd.	Shenzhen OSTOTechnology Co., Ltd.
Device Name andModel	KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221,KTR-2211, KTR-2232, KTR-2222, KTR2212	Pain Therapy DeviceModels: P.T.S-II, P.T.S-IIA, P.T.S-IIB, CP-I	Intelligent WirelessFitness ApparatusModels: AST-301, AST-302, AST-303
510(k) Number	K191982	K163611	K182136
Product Code	NUH, NGX	NUH, NGX, NYN	NGX

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Regulation Number	882.5890, 890.5850	882.5890, 890.5850	890.5850
Regulation Class	II	II	II
Primary/ Referencedevice	Primary predicate device	Reference device	Reference device

5. Intended Use / Indications for Use

KTR-2240, KTR-2250, KTR-2610, KTR-2640, KTR-2650: (TENS, EMS, FITNESS)

TENS (Mode 1~20): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.

EMS (Mode 21~40): It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.

FITNESS (Mode 41~50): Improvement of abdominal tone, strengthening of the abdominal muscle development of firmer abdomen.

KTR-2241, KTR-2251, KTR-2242, KTR-2252, KTR-2611, KTR-2641, KTR-2651, KTR-2612, KTR-2642, KTR-2652: (TENS)

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

6. Device Description

The electronic stimulatory module has the operating elements of ON/OFF Key, Display screen, Mode Selection key and Intensity Modification keys.

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

The device is equipped with accessories of electrode wires, and batteries. The electrode wire is used to connect the patches to the main unit.

The electrode pads are complying with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization), are interchangeable.

7. Test Summary

Low-frequency Multi-function physiotherapy instrument has been evaluated the safety and performance by lab bench testing as following:

� Electrical safety test according to IEC 60601-1-11 and IEC 60601-2-10 standards
� Electromagnetic compatibility test according to IEC 60601-1-2 standard
� Usability test according to IEC 62366-1 standard
� 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 body-contacting components of this device are electrode patches. We have directly purchased the electrode patches from qualified supplier (Shenzhen Quality Medical Technology Co., Ltd.) 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.

� ISO 10993-5: 2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
� ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization

8. Comparison to predicate device and conclusion

The technological characteristics, features, specifications, materials, mode of operation, and intended use of Low-frequency Multi-function physiotherapy instrument 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.

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Elements of Comparison	Subject Device	Predicate Device 1(Primary predicatedevice)	Predicate Device 2(Reference Device)	Predicate Device 3(Reference Device)	Remark
Device Name and Model	Low-frequency Multi-function physiotherapyinstrumentModel: KTR-2240,KTR-2250, KTR-2241,KTR-2251, KTR-2242,KTR-2252, KTR-2610,KTR-2640, KTR-2650,KTR-2611, KTR-2641,KTR-2651, KTR-2612,KTR-2642, KTR-2652	Low-frequency Multi-functionphysiotherapyinstrumentModel: KTR-2230,KTR-2220, KTR-2210, KTR-2231,KTR-2221, KTR-2211, KTR-2232,KTR-2222, KTR-2212	Pain Therapy Device,Models: P.T.S-II,P.T.S-IIA, P.T.S-IIB,CP-I	Intelligent WirelessFitness ApparatusModels: AST-301,AST-302, AST-303	--
510(k) Number	K200177	K191982	K163611	K182136	--
Product code	NUH, NGX	NUH, NGX	NUH, NYN, NGX	NGX	SE
Intended Use	KTR-2240, KTR-2250,KTR-2610, KTR-2640,KTR-2650: (TENS,EMS, FITNESS)TENS (Mode 120):To be used for temporaryrelief of painassociated with soreand aching muscles inthe shoulder, waist,back, back of the neck,arm, leg, and foot dueto strain from exerciseor normal householdwork activities byapplying current tostimulate nerve.EMS (Mode 2140): Itis intended to stimulatehealthy muscles inorder to improve and	KTR-2210, KTR-2220, KTR-2230:(TENS, EMS,FITNESS)TENS (Mode 120):To be used fortemporary relief ofpain associated withsore and achingmuscles in theshoulder, waist, back,back of the neck, arm,leg, and foot due tostrain from exerciseor normal householdwork activities byapplying current tostimulate nerve.EMS (Mode 2140): Itis intended tostimulate healthy	To be used fortemporary relief ofpain associated withsore and achingmuscles in the upperand lower back, backof the neck, upperextremities (shoulderand arm), lowerextremities (leg andfeet) due to strain fromexercise or normalhousehold workactivities by applyingcurrent to stimulatenerve.To be used forsymptomatic relief andmanagement ofchronic, intractablepain and relief of pain	Intelligent WirelessFitness Apparatus isindicated to be usedfor: Improvement ofabdominal tone,strengthening of theabdominal musclesdevelopment of firmerabdomen.Strengthening, toningand firming of buttocksand thighs.	SE
Elements of Comparison	Subject Device	Predicate Device 1(Primary predicatedevice)	Predicate Device 2(Reference Device)	Predicate Device 3(Reference Device)	Remark
Power Source(s)	facilitate muscleperformance.FITNESS (Mode41~50): Improvementof abdominal tone,strengthening of theabdominal muscledevelopment of firmerabdomen.KTR-2241, KTR-2251,KTR-2242, KTR-2252,KTR-2611, KTR-2641,KTR-2651, KTR-2612,KTR-2642, KTR-2652:(TENS)To be used fortemporary relief of painassociated with soreand aching muscles inthe shoulder, waist,back, back of the neck,arm, leg, and foot dueto strain from exerciseor normal householdwork activities byapplying current tostimulate nerve.	muscles in order toimprove and facilitatemuscle performance.FITNESS (Mode41~50): Improvementof abdominal tone,strengthening of theabdominal musclesdevelopment of firmerabdomen.KTR-2211, KTR-2221, KTR-2231,KTR-2212, KTR-2222, KTR-2232:(TENS)To be used fortemporary relief ofpain associated withsore and achingmuscles in theshoulder, waist, back,back of the neck, arm,leg, and foot due tostrain from exerciseor normal householdwork activities byapplying current tostimulate nerve.	associated witharthritis (Choose ModeB or C).To stimulate healthymuscles in order toimprove and facilitatemuscle performance(Choose Mode A).To temporarilyincrease local blood.
Power Source(s)	For model KTR-2240,KTR-2250, KTR-2241,KTR-2251, KTR-2242,KTR-2252: DC 4.5V(3xAAA LR03 battery),180mAFor model KTR-2610	DC 4.5V (3*AAALR03 battery), 180mA	DC 3.0V, 2 x AAA	Adapter (ModelHDMU05E-050100,HDMU05B-050100,HDMU05U-050100)Input: 100-240 Vac;50/60 Hz; 0,3A;Output: 5 V; 1A	SE
Elements of Comparison	Subject Device	Predicate Device 1(Primary predicatedevice)	Predicate Device 2(Reference Device)	Predicate Device 3(Reference Device)	Remark
	KTR-2640, KTR-2650,KTR-2611, KTR-2641,KTR-2651, KTR-2612,KTR-2642, KTR-2652:3.7V/250mAh lithiumbattery			Rechargeable Lithium-ion Battery: 3.7Vdc
-Method of Line Current Isolation	Type BF Applied Part	Type BF Applied Part	Type BF Applied Part	Type BF Applied Part	SE
Patient LeakageCurrent	NC	DC: 0.5µA	DC: 0.5μA	DC: 0.5μA	< 0.01μA
	SFC	DC: 0.6μA	DC: 0.6μA	DC: 0.6μA	0.1mA
Average DC current throughelectrodes when device is on but nopulses are being applied	< 0.01μA	< 0.01μA	< 0.01	Not publicly available	SE
Number of Output Channels:	2 channels	2 channels	2 Channels: formodels P.T.S-II,P.T.S-IIA, P.T.S-IIB;1 Channel: formodel CP-I	2	SE
Number of Output Modes	For model KTR-2240,KTR-2250, KTR-2610,KTR-2640, KTR-2650:50 modes;	50	3	8	SE

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Elements of Comparison	Subject Device	Predicate Device 1(Primary predicatedevice)	Predicate Device 2(Reference Device)	Predicate Device 3(Reference Device)	Remark
	KTR-2251, KTR-2242,KTR-2252, KTR-2611,KTR-2641, KTR-2651,KTR-2612, KTR-2642,KTR-2652: 15 modes
Output Intensity Level	16 steps	16 steps	5 steps	Not publicly available	SE
Synchronous or Alternating?	Synchronous	Synchronous	Synchronous	Alternating	SE
Method of Channel Isolation	Voltage TransformIsolation"Ch1+" and "Ch1-"buttons for channel 1,"Ch2+" and "Ch2-"buttons for channel 2	Voltage TransformIsolation"Ch1+" and "Ch1-"buttons for channel 1,"Ch2+" and "Ch2-"buttons for channel 2	Parallel connection	Voltage TransformIsolation	SE
Regulated Current or RegulatedVoltage?	Voltage Control	Voltage Control	Regulated Voltage	Voltage Control	SE
Software/Firmware/MicroprocessorControl?	Yes	Yes	Yes	Yes	SE
Automatic Overload Trip	No	No	No	No	SE
Automatic No-Load Trip	No	No	No	No	SE
Automatic Shut Off	Yes	Yes	Yes	Yes	SE
User Override Control	Yes	Yes	Yes	Yes	SE
On/Off Status	Yes	Yes	Yes	Yes	SE
Indicator Display	On/Off Status	Yes	Yes	Yes	Yes	SE
	Low Battery	Yes	No	No	Yes	SE
Voltage/ CurrentLevel	Yes	Yes	Yes	Yes	SE
Timer Range	15, 30, 45min	15, 30, 45min	10, 20, 40 min	15 min	SE
Weight	For model KTR-2240,KTR-2241, KTR-2242:110gFor model KTR-2250	KTR-2210, KTR-2211, KTR-2212: 76gKTR-2220, KTR-2221, KTR-2222: 82g	Main Unit:P.T.S-II: 75gP.T.S-IIA: 100g	80g (Withoutaccessories)	SENote 1

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

Elements of Comparison	Subject Device	Predicate Device 1(Primary predicatedevice)	Predicate Device 2(Reference Device)	Predicate Device 3(Reference Device)	Remark
	KTR-2251, KTR-2252:114gFor model KTR-2610,KTR-2611, KTR-2612:70gFor model KTR-2640,KTR-2641, KTR-2642:68gFor model KTR-2650,KTR-2651, KTR-2652:71g	KTR-2230, KTR-2231, KTR-2232: 75gElectrode :12gElectrode wire: 12g	CP-I: 66gElectrode:Big Patch Electrode:40gSmall PatchElectrode:10gInsole Electrode: 200gSole Plant Electrode A(only for CP-I): 900gSole Plant Electrode B:920g
Dimensions	Main unit:For model KTR-2240,For model KTR-2240,KTR-2241, KTR-2242:122mm x 55mm x21mm;For model KTR-2250,KTR-2251, KTR-2252:122mm x 55mm x21.6mm;For model KTR-2610,KTR-2611, KTR-2612:122mm x 55mm x15.7mm;For model KTR-2640,KTR-2641, KTR-2642:122mm x 55mm x14.9mm;For model KTR-2650,KTR-2651, KTR-2652:122mm x 55mm x15.5mmElectrode Pads: 3kinds	Main unit: KTR 2210,KTR-2211, KTR-2212: 122mm * 55mm* 21.8mm;KTR-2220, KTR-2221, KTR-2222,KTR-2230, KTR-2231and KTR- 2232:120mm * 55mm *20.4mmElectrode: Squareshape: 50mm x50mm (Area: 25cm2)Irregularly shape:about 50mm x 70mm(Area: about 30cm2)	Main Unit:P.T.S-II: 110 x 78 x 20mmP.T.S-IIA: 135 x 82 x20 mmP.T.S-IIB: 135 x 82 x20 mmCP-I: 92 x 78 x 20mmElectrode:Large Patch Electrode:120 x 80 mmSmall Patch Electrode:46 x 46mmInsole Electrode:260 x 110 mmSole Plant ElectrodeA (only for CP-I):450 x 450 x 90 mmSole Plant Electrode B:450 x 450 x 90 mm	Main Unit: 50X37mmElectrode pad formodel AST-301:198mm x 164mm x2mmElectrode pad formodel AST-302:192mm x 164mm x2mmElectrode pad formodel AST-303: 125mm x 80mm x 2mmEach gel sheet 90mm x60mm x2 mm	SENote 1
Elements of Comparison	Subject Device	Predicate Device 1(Primary predicatedevice)	Predicate Device 2(Reference Device)	Predicate Device 3(Reference Device)	Remark
	EPAD-D01: 70x52mmEPAD-D02: 50x50mmEPAD-D03: 50x50mm
Housing Materials and Construction	Main unit: ABS plastic	Main unit: ABS plastic	Main unit: ABS plastic	Main unit: ABS plastic	SE
Waveform	Pulsed, symmetric,biphasic	Pulsed, symmetric,biphasic	Pulsed, symmetric,biphasic	Pulsed, Symmetrical,Biphasic	SE
Shape	Rectangular, withinterphase interval	Rectangular, withinterphase interval	Rectangular, withinterphase interval	Rectangular, withinterphaseinterval	SE
	46.0V±10% @ 500Ω	55V±10% @ 500Ω	40V±10% @ 500Ω	44V±10% @ 500Ω
Maximum Output Voltage	57.5V±10% @ 2KΩ	75V±10% @ 2KΩ	80V±10% @ 2KΩ	80V±10% @ 2KΩ	SENote 2*
	66.5V±10% @ 10KΩ	85V±10% @ 10KΩ	95V±10% @ 10KΩ	112V±20% @ 10KΩ
	92mA±10% @ 500Ω	110mA±10% @ 500Ω	80mA±10% @ 500Ω	88mA±10% @ 500Ω	SENote 2*
Maximum Output Current	28.8mA±10% @ 2KΩ	37.5mA±10% @ 2KΩ	40mA±10% @ 2KΩ	40mA±10% @ 2KΩ
	6.65mA±10% @ 10KΩ	8.5mA±10% @10KΩ	9.5mA±10% @10Ω	11.2mA±10% @10KΩ
Pulse Duration	TENS: 120µs, EMS:200µs, FITNESS:200µs	TENS: 120µs, EMS:200µs, FITNESS:200µs	200µs	120µs	SE
Pulse frequency	TENS:(20-100) Hz,EMS:(1-15) Hz,FITNESS:(2-16) Hz	TENS:(20-100) Hz,EMS:(1-15) Hz,FITNESS:(2-16) Hz	13.7~48.5Hz	8.33Hz	SE
Net Charge (per pulse)	0µC @ 500Ω,Method: Balancedwaveform	0µC @ 500ΩMethod: Balancedwaveform	0µC @ 500Ω,Method: Balancedwaveform	10.56µC @ 500Ω	SE
Maximum Phase Charge	18.40µC @ 500Ω	15.97 µC @ 500Ω,	19.2µC @ 500Ω	12.78µC @ 500Ω	SENote 2*
Maximum Average Current	3.20mA	1.60mA	1.53mA @ 500Ω	1.69mA @ 500Ω	SENote 2*
Elements of Comparison	Subject Device	Predicate Device 1(Primary predicatedevice)	Predicate Device 2(Reference Device)	Predicate Device 3(Reference Device)	Remark
Maximum Average Power Density	$0.204mW/cm^2 @500Ω$	$0.08mW/cm^2$	$0.056mW/cm^2 @500Ω$	$15.37μW/cm^2 @500Ω$	SENote 2*
Maximum Average Current Density	$0.1279mA/cm^2@ 500Ω$	$0.064mA/cm^2 @500Ω$	$0.073mA/cm^2@500Ω$	$0.26 mA/cm^2 @500Ω$	SENote 2*
ON Time	0.6s	0.6s	2s	3s	SE
OFF Time	0.6s	0.6s	2s	3s	SE
Environment for operating	Environmenttemperature: +5°C-+40°C;Environment humidity:15%-93%RH;Atmosphericenvironmentconditions: 700hPa-1060hPa	Environmenttemperature: +5°C-+40°C;Environmenthumidity: 15%-93%RH;Atmosphericenvironmentconditions: 700hPa-1060hPa	Temperature: 5~~40°C,Humidity: ≤80%RH,Atmospheric Pressure86~~106kPa	0°C to +40°C	SE
Environment for storage	Environmenttemperature: 0°C-+55°C;Environment humidity:0-93%RH;Atmosphericenvironmentconditions: 700hPa-1060hPa.	Environmenttemperature: -25°C-+70°C;Environmenthumidity: 0-93%RH;Atmosphericenvironmentconditions: 700hPa-1060hPa.	Temperature:Main Unit: -20~~55°C,Electrode Pad:10~~20°CHumidity: 10~~95% RHAtmospheric Pressure:50~~106 kPa	Not publicly available	SE
Biocompatibility	All user directlycontacting materialsare compliance withISO 10993-5 and ISO10993-10requirements.	All user directlycontacting materialsare compliance withISO 10993-5 and ISO10993-10requirements.	All user directlycontacting materialsare compliance withISO 10993-5 and ISO10993-10requirements.	All user directlycontacting materialsare compliance withISO 10993-5 and ISO10993-10requirements.	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	Comply with IEC60601-1 and 60601-2-10	SE
Elements of Comparison	Subject Device	Predicate Device 1(Primary predicatedevice)	Predicate Device 2(Reference Device)	Predicate Device 3(Reference Device)	Remark
EMC	Comply with IEC60601-1-2	Comply with IEC60601-1-2	Comply with IEC60601-1-2	Comply with IEC60601-1-2	SE

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*More detail information please refer to the Supplement SE table for all modes output specifications

Supplement SE table for all modes output specifications
	Subject device	Predicate device 1(K191982)	Reference device 2(K163611)	Reference device 3(K182136)	Remark
PulseDuration	TENS: 120µs, EMS: 200µs, FITNESS:200µs	TENS: 120µs, EMS:200µs, FITNESS:200µs	200µs	120µs	SE
Pulsefrequency	TENS:(20-100) Hz, EMS:(1-15) Hz,FITNESS:(2-16) Hz	TENS:(20-100) Hz,EMS:(1-15) Hz,FITNESS:(2-16) Hz	13.7~48.5Hz	8.33Hz	SENote 2
MaximumOutputVoltage±10% @500Ω	For model KTR-2240, KTR-2250,KTR-2610, KTR-2640, KTR-2650:Mode 1: 41.3VMode 2: 40.0VMode 3: 42.4VMode 4: 43.0VMode 5: 41.6VMode 6: 38.4VMode 7: 40.3VMode 8: 38.4VMode 9: 38.0VMode 10: 39.6VMode 11: 37.8VMode 12: 37.4VMode 13: 36.2VMode 14: 27.2VMode 15: 38.2VMode 16: 38.2VMode 17: 37.2VMode 18: 37.4VMode 19: 27.3VMode 20: 22.2VMode 21: 40.4VMode 22: 46.0VMode 23: 41.2VMode 24: 41.0VMode 25: 41.2VMode 26: 40.4VMode 27: 40.0VMode 28: 40.8V	55V±10%	40V±10%	44V±10%	SENote 2

	Mode 29: 39.5VMode 30: 39.6VMode 31: 21.6VMode 32: 21.8VMode 33: 21.6VMode 34: 21.2VMode 35: 21.2VMode 36: 21.6VMode 37: 21.6VMode 38: 21.6VMode 39: 20.0VMode 40: 20.8VMode 41: 39.3VMode 42: 39.5VMode 43: 38.2VMode 44: 38.2VMode 45: 37.6VMode 46: 37.5VMode 47: 37.8VMode 48: 37.6VMode 49: 37.6VMode 50: 37.8VFor model KTR-2241, KTR-2251,KTR-2242, KTR-2252, KTR-2611,KTR-2641, KTR-2651, KTR-2612,KTR-2642, KTR-2652:Mode 1: 41.3VMode 2: 40.0VMode 3: 42.4VMode 4: 43.0VMode 5: 41.6VMode 6: 38.4VMode 7: 40.3VMode 8: 37.8VMode 9: 36.2VMode 10: 40.3VMode 11: 41.3VMode 12: 43.0VMode 13: 41.6VMode 14: 40.3VMode 15: 37.8V
MaximumOutputCurrent±10% @500Ω	For model KTR-2240, KTR-2250,KTR-2610, KTR-2640, KTR-2650:Mode 1: 82.6mAMode 2: 80.0mAMode 3: 84.8mAMode 4: 86.0mAMode 5: 83.2mAMode 6: 76.8mAMode 7: 80.6mAMode 8: 76.8mAMode 9: 76.0mAMode 10: 79.2mAMode 11: 75.6mAMode 12: 74.8mAMode 13: 27.4mAMode 14: 54.4mAMode 15: 76.4mAMode 16: 76.4mAMode 17: 74.4mAMode 18: 74.8mAMode 19: 54.6mAMode 20: 44.4mAMode 21: 80.8mAMode 22: 92.0mAMode 23: 82.4mAMode 24: 82.0mAMode 25: 82.4mAMode 26: 80.8mA	110mA±10% @ 500Ω	80mA±10% @ 500Ω	88mA±10% @ 500ΩSENote 2

	Mode 27: 80.0mAMode 28: 81.6mAMode 29: 79.0mAMode 30: 79.2mAMode 31: 43.2mAMode 32: 43.6mAMode 33: 43.2mAMode 34: 42.4mAMode 35: 42.4mAMode 36: 43.2mAMode 37: 43.2mAMode 38: 43.2mAMode 39: 40.0mAMode 40: 41.6mAMode 41: 78.9mAMode 42: 79.0mAMode 43: 76.4mAMode 44: 76.4mAMode 45: 75.2mAMode 46: 75.0mAMode 47: 75.6mAMode 48: 75.2mAMode 49: 75.2mAMode 50: 75.6mAFor model KTR-2241, KTR-2251,KTR-2242, KTR-2252, KTR-2611,KTR-2641, KTR-2651, KTR-2612,KTR-2642, KTR-2652:Mode 1: 82.6mAMode 2: 80.0mAMode 3: 84.8mAMode 4: 86.0mAMode 5: 83.2mAMode 6: 76.8mAMode 7: 80.6mAMode 8: 75.6mAMode 9: 72.4mAMode 10: 80.6mAMode 11: 82.6mAMode 12: 86mAMode 13: 83.2mAMode 14: 80.6mAMode 15: 75.6mA
MaximumPhaseCharge$\mu$ C@500Ω	For model KTR-2240, KTR-2250,KTR-2610, KTR-2640, KTR-2650:Mode 1: 9.91 $\mu$ CMode 2: 9.60 $\mu$ CMode 3: 10.18 $\mu$ CMode 4: 10.32 $\mu$ CMode 5: 9.98 $\mu$ CMode 6: 9.22 $\mu$ CMode 7: 9.67 $\mu$ CMode 8: 9.22 $\mu$ CMode 9: 9.124 $\mu$ CMode 10: 9.50 $\mu$ CMode 11: 9.07 $\mu$ CMode 12: 8.98 $\mu$ CMode 13: 8.69 $\mu$ CMode 14: 6.53 $\mu$ CMode 15: 9.170 $\mu$ CMode 16: 9.17 $\mu$ CMode 17: 8.93 $\mu$ CMode 18: 8.98 $\mu$ CMode 19: 6.55 $\mu$ CMode 20: 5.33 $\mu$ CMode 21: 16.16 $\mu$ CMode 22: 18.40 $\mu$ CMode 23: 16.48 $\mu$ CMode 24: 16.40 $\mu$ C	15.97 $\mu$ C @ 500Ω	19.2 $\mu$ C @ 500Ω	12.78 $\mu$ C @ 500Ω	SENote 2

	Mode 25: 16.48µC Mode 26: 16.16µCMode 27: 16.00µC Mode 28:16.32µCMode 29: 15.80µC Mode 30: 15.84µCMode 31: 8.64µC Mode 32: 8.726µCMode 33: 8.64µC Mode 34: 8.48µCMode 35: 8.48µC Mode 36: 8.64µCMode 37: 8.64µC Mode 38: 8.64µCMode 39: 8.00µC Mode 40: 8.32µCMode 41: 15.72µC Mode 42: 15.80µCMode 43: 15.28µC Mode 44: 15.28µCMode 45: 15.04µC Mode 46: 15.00µCMode 47: 15.12µC Mode 48: 15.04µCMode 49: 15.04µC Mode 50: 15.12µCFor model KTR-2241, KTR-2251,KTR-2242, KTR-2252, KTR-2611,KTR-2641, KTR-2651, KTR-2612,KTR-2642, KTR-2652:Mode 1: 9.91µC Mode 2: 9.60µCMode 3: 10.18µC Mode 4: 10.32µCMode 5: 9.98µC Mode 6: 9.22µCMode 7: 9.67µC Mode 8: 9.07µCMode 9: 8.69µC Mode 10: 9.67µCMode 11: 9.91µC Mode 12: 10.32µCMode 13: 9.98µC Mode 14: 9.67µCMode 15: 9.07µC
MaximumAverageCurrent@500Ω	For model KTR-2240, KTR-2250,KTR-2610, KTR-2640, KTR-2650:Mode 1: 0.40mA Mode 2: 0.48mAMode 3: 0.61mA Mode 4: 0.83mAMode 5: 1.00mA Mode 6: 1.11mAMode 7: 1.93mA Mode 8: 0.74mAMode 9: 0.91mA Mode 10: 1.14mAMode 11: 1.45mA Mode 12: 1.80mA	1.60mA	1.53mA @ 500Ω	1.69mA @ 500Ω	SENote 2

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{15}------------------------------------------------

{16}------------------------------------------------

{17}------------------------------------------------

Mode 13: 2.08mA	Mode 14: 2.61mA
Mode 15: 1.10mA	Mode 16: 1.38mA
Mode 17: 1.61mA	Mode 18: 2.15mA
Mode 19: 2.36 mA	Mode 20: 3.20mA
Mode 21: 0.10mA	Mode 22: 0.22mA
Mode 23: 0.30mA	Mode 24: 0.49mA
Mode 25: 0.59mA	Mode 26: 0.68mA
Mode 27: 0.86mA	Mode 28:0.98mA
Mode 29: 1.14mA	Mode 30: 1.43mA
Mode 31: 0.03mA	Mode 32: 0.05mA
Mode 33: 0.08mA	Mode 34: 0.13mA
Mode 35: 0.15mA	Mode 36: 0.18mA
Mode 37: 0.23mA	Mode 38: 0.26mA
Mode 39: 0.29mA	Mode 40: 0.37mA
Mode 41: 0.06mA	Mode 42: 0.09mA
Mode 43: 0.15mA	Mode 44: 0.21mA
Mode 45: 0.24mA	Mode 46: 0.27mA
Mode 47: 0.30mA	Mode 48: 0.33mA
Mode 49: 0.39mA	Mode 50: 0.48mA
For model KTR-2241, KTR-2251,KTR-2242, KTR-2252, KTR-2611,KTR-2641, KTR-2651, KTR-2612,KTR-2642, KTR-2652:
Mode 1: 0.40mA	Mode 2: 0.48mA
Mode 3: 0.61mA	Mode 4: 0.83mA
Mode 5: 1.00mA	Mode 6: 1.11mA
Mode 7: 1.93mA	Mode 8: 1.45mA
Mode 9: 2.08mA	Mode 10: 1.93mA
Mode 11: 0.40mA	Mode 12: 0.83mA
Mode 13: 1.00mA	Mode 14: 1.93mA
Mode 15: 1.45mA

{18}------------------------------------------------

MaximumAveragePowerDensitymW/cm²@500Ω	For model KTR-2240, KTR-2250,KTR-2610, KTR-2640, KTR-2650:					MaximumAverageCurrentDensitymA/cm²@500Ω	For model KTR-2240, KTR-2250,KTR-2610, KTR-2640, KTR-2650:
	Mode 1: 0.0031Mode 2: 0.0046Mode 3: 0.0074Mode 4: 0.0136Mode 5: 0.0199Mode 6: 0.0244Mode 7: 0.0748Mode 8: 0.0108Mode 9: 0.0166Mode 10: 0.0260Mode 11: 0.0421Mode 12: 0.0644Mode 13: 0.0869Mode 14: 0.1363Mode 15: 0.0242Mode 16: 0.0378Mode 17: 0.0516Mode 18: 0.0928Mode 19: 0.1112Mode 20: 0.2044Mode 21: 0.0002Mode 22: 0.0009Mode 23: 0.0017Mode 24: 0.0048Mode 25: 0.0070Mode 26: 0.0092Mode 27: 0.0149Mode 28: 0.0192Mode 29: 0.0259Mode 30: 0.0406Mode 31: 0.0001Mode 32: 0.0001Mode 33: 0.0001Mode 34: 0.0003Mode 35: 0.0005Mode 36: 0.0007Mode 37: 0.0011Mode 38: 0.0013Mode 39: 0.0017Mode 40: 0.0028Mode 41: 0.0001Mode 42: 0.0002Mode 43: 0.0005Mode 44: 0.0009Mode 45: 0.0012Mode 46: 0.0015Mode 47: 0.0018Mode 48: 0.0022Mode 49: 0.0031Mode 50: 0.0047	0.08mW/cm² @ 500Ω	0.056m W/cm² @500Ω	Not publicly available	SENote 2		Mode 1: 0.0159 Mode 2: 0.0192Mode 3: 0.0244 Mode 4: 0.0330Mode 5: 0.0399 Mode 6: 0.0442Mode 7: 0.0774 Mode 8: 0.0295Mode 9: 0.0365 Mode 10: 0.0456Mode 11: 0.0581 Mode 12: 0.0718Mode 13: 0.0834 Mode 14: 0.1044Mode 15: 0.0440 Mode 16: 0.0550Mode 17: 0.0643 Mode 18: 0.0862Mode 19: 0.0943 Mode 20: 0.1279Mode 21: 0.0039 Mode 22: 0.0088Mode 23: 0.0119 Mode 24: 0.0197Mode 25: 0.0237 Mode 26: 0.0271Mode 27: 0.0346 Mode 28: 0.0392Mode 29: 0.0455 Mode 30: 0.0570Mode 31: 0.0010 Mode 32: 0.0021Mode 33: 0.0031 Mode 34: 0.0051Mode 35: 0.0061 Mode 36: 0.0073Mode 37: 0.0093 Mode 38: 0.0104Mode 39: 0.0115 Mode 40: 0.0150Mode 41: 0.0025 Mode 42: 0.0038Mode 43: 0.0061 Mode 44: 0.0086Mode 45: 0.0096 Mode 46: 0.0108Mode 47: 0.0121 Mode 48: 0.0132Mode 49: 0.0156 Mode 50: 0.0194	0.064mA/cm²@500Ω	0.073mA/cm²@500Ω	0.026 mA/cm² @500Ω	SENote 2
	For model KTR-2241, KTR-2251,KTR-2242, KTR-2252, KTR-2611,KTR-2641, KTR-2651, KTR-2612,KTR-2642, KTR-2652:Mode 1: 0.0031Mode 2: 0.0046Mode 3: 0.0075Mode 4: 0.0136Mode 5: 0.0199Mode 6: 0.0245Mode 7: 0.0748Mode 8: 0.0421Mode 9: 0.0869Mode 10: 0.0748Mode 11: 0.0031Mode 12: 0.0136Mode 13: 0.0199Mode 14: 0.0745Mode 15: 0.0421						For model KTR-2241, KTR-2251,KTR-2242, KTR-2252, KTR-2611,KTR-2641, KTR-2651, KTR-2612,KTR-2642, KTR-2652:Mode 1: 0.0159 Mode 2: 0.0192Mode 3: 0.0224 Mode 4: 0.0330Mode 5: 0.0399 Mode 6: 0.0442Mode 7: 0.0774 Mode 8: 0.0581Mode 9: 0.0834 Mode 10: 0.0774Mode 11: 0.0159 Mode 12: 0.0330Mode 13: 0.0399 Mode 14: 0.0774Mode 15: 0.0581

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Comparison in Detail(s):

Note 1:

Although the "Weight" and "Dimensions" are a little different from the predicate device, but these are not critical parameter for effectiveness, but they all met the requirements of the same standard as 60601-1-2. So, the differences between the subject device and predicate devices will not raise any safety or effectiveness.

Note 2:

Although the "Maximum Output Current", "Maximum Phase Charge", "Maximum Average Current", "Maximum Current Density (r.m.s)", "Maximum Average Power Density" are a little different from the predicate devices, but they all meet the requirements of the same standards as IEC 60601-2-10. So. the differences between the subject device and predicate devices will not raise any safety or effectiveness.

Finial Conclusion:

The conclusion drawn from the nonclinical tests demonstrate that the subject devices Multi-function physiotherapy instrument (Model: KTR-2240, KTR-2250, KTR-2251, KTR-2242, KTR-2610, KTR-2640, KTR-2640, KTR-2611, KTR-2641, KTR-2641, KTR-2641, KTR-2641, KTR-2651, KTR-2612, KTR-2642, KTR-2652) as safe, as effective as well as the legally marketed device identified in K191982. K163611 and K182136.

Date of the summary prepared: March 3, 2021

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).