(269 days)
Transcutaneous Electronic Nerve Stimulator is indicated for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
Transcutaneous Electronic Nerve Stimulator (Models: KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2491, KTR-2492, KTR-2493, KTR-2494) is a portable and battery powered multifunctional device, offering Transcutaneous Electronic Nerve Stimulator. They can give certain electrical pulse through electrode pads placed on the skin to help users to enjoy body stimulation.
For models: KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2301, KTR-2302, KTR-2342 have 3 operation modes:
For models: KTR-2491, KTR-2493, KTR-2493, KTR-2494 have 15 operation modes, 9 manual mode, and 6 automatic mode. They can be remotely controlled with an accessory remote control. And there is a LCD displays on remote control, which display mode and treatment time.
The electronic stimulator module has unified the operating elements of ON/OFF button. Intensity adjust button and Mode selection button.
The device is equipped with accessories of electrode pads, batteries and remote control (For KTR-249X series).
The electrode pads are complying with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization), are interchangeable.
The provided text describes a 510(k) premarket notification for a Transcutaneous Electronic Nerve Stimulator (TENS) and does not contain information about acceptance criteria and a study proving the device meets those criteria, as typically understood in the context of diagnostic or prognostic AI/ML medical devices.
Instead, this document is a regulatory submission demonstrating substantial equivalence to previously cleared predicate devices. The "Test Summary" and "Comparison to predicate device" sections outline engineering tests and comparisons of technical specifications, rather than clinical performance studies against specific acceptance criteria for diagnostic accuracy.
Therefore, an output table as requested cannot be fully populated. However, I can extract the relevant information regarding the tests performed to support the "substantial equivalence" claim.
Here's a breakdown of what is available:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission for a TENS device, the "acceptance criteria" are related to industrial standards and engineering specifications rather than diagnostic performance metrics (e.g., sensitivity, specificity, AUC) typically seen with AI/ML devices. The reported "performance" is compliance with these standards and comparison of technical specifications to predicate devices.
| Acceptance Criterion (Standard/Parameter) | Reported Device Performance (Compliance/Value) |
|---|---|
| Electrical safety | Complies with IEC 60601-1, IEC 60601-1-11, IEC 60601-2-10 |
| Electromagnetic compatibility (EMC) | Complies with IEC 60601-1-2 |
| Biocompatibility | Complies with ISO 10993-1, ISO 10993-5, ISO 10993-10 (for electrode pads) |
| Usability | Complies with IEC 62366-1 |
| Software verification and validation | Complies with FDA "Guidance for Pre-Market Submissions and for Software Contained in Medical Devices" |
| Waveform output specifications | Verified by waveform test report according to FDA guidance for TENS and Powered Muscle Stimulator |
| Patient Leakage Current (NC DC) | 0.5µA (Matches predicate) |
| Patient Leakage Current (SFC DC) | 0.6μΑ (Matches predicate) |
| Average DC current through electrodes (device on, no pulses) | < 0.01μΑ (Matches predicate) |
| Number of Output Channels | 1 channel (Matches primary predicate) |
| Number of Output Modes | 3-15 modes (Compared to 3-5 modes for predicates) |
| Output Intensity Level | 16 steps (Compared to 5, 15, 16 steps for predicates) |
| Synchronous or Alternating | Synchronous (Matches predicates where known) |
| Regulated Current or Voltage | Voltage Control (Matches predicates where known) |
| Software/Firmware/Microprocessor Control | Yes (Matches predicates) |
| Automatic Overload Trip | No (Matches predicates where known) |
| Automatic No-Load Trip | No (Matches predicates where known) |
| Automatic Shut Off | Yes (Matches predicates where known) |
| User Override Control | Yes (Matches predicates where known) |
| On/Off Status Indicator | Yes (Matches predicates where known) |
| Low Battery Indicator | No (Matches predicates where known) |
| Display Voltage/Current Level | Yes (Matches predicates where known) |
| Timer Range | 15 min (Compared to 10, 20, 25, 40 min range for predicates) |
| Maximum Output Voltage (@500Ω, 2KΩ, 10KΩ) | 43.6V±10% @ 500Ω, 59V±10% @ 2KΩ, 66.5V±10% @ 10KΩ (Compared to similar ranges for predicates. Note 2 states similar maximum peak voltage) |
| Maximum Output Current (@500Ω, 2KΩ, 10KΩ) | 87.2mA±10% @ 500Ω, 29.5mA±10% @ 2KΩ, 6.65mA±10% @ 10KΩ (Compared to similar ranges for predicates. Note 2 states similar maximum peak voltage) |
| Pulse Duration | 120µs (Compared to 65-224µs range for predicates) |
| Pulse Frequency | 20-100Hz (Compared to 1-110Hz range for predicates) |
| Net Charge (per pulse) | 0µC @ 500Ω, Balanced waveform (Matches predicates where known) |
| Maximum Phase Charge | 12.66µC @ 500Ω (Compared to 7.67-33.07µC range for predicates) |
| Maximum Current Density (mA/cm², r.m.s.) (@500Ω) | 0.058 mA/cm² (Compared to 0.154-0.437 mA/cm² for predicates) |
| Maximum Average Power Density (@500Ω) | 0.037 mW/cm² (Compared to 0.0008-1.2 mW/cm² for predicates) |
| Operating Environment | Temperature: +5°C-+40°C, Humidity: 0%-80%RH, Atmospheric pressure: 860hPa-1060hPa (Matches predicates where known) |
| Storage Environment | Temperature: 0°C-+55°C, Humidity: 0-93%RH, Atmospheric pressure: 500hPa-1060hPa (Matches predicates where known) |
| Housing Materials and Construction | Main unit: ABS plastic (Matches predicates) |
| Waveform | Pulsed, symmetric, biphasic (Differs from one predicate, but matches others) |
| Shape | Rectangular, with interphase interval (Differs from one predicate, but matches others) |
2. Sample size used for the test set and the data provenance
The document does not describe a clinical "test set" and therefore does not specify a sample size or data provenance in the context of clinical performance evaluation (e.g., diagnostic accuracy). The testing described is primarily engineering bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. "Ground truth" in the context of expert consensus for AI/ML performance is not discussed for this device. The evaluations were based on compliance with engineering standards.
4. Adjudication method for the test set
Not applicable. There was no clinical "test set" 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 a TENS device, not an AI/ML diagnostic or prognostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a TENS device, not an AI/ML algorithm. Its performance is inherent in its electrical output and user interface, which are assessed through engineering and usability tests.
7. The type of ground truth used
For the engineering tests (electrical safety, EMC, biocompatibility, usability, software verification, waveform output), the "ground truth" is defined by the requirements and specifications within the referenced international standards (IEC 60601 series, ISO 10993 series, IEC 62366-1) and FDA guidance documents. Compliance is assessed against these established technical benchmarks.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
Summary of the study that proves the device meets the acceptance criteria (based on available information):
The device's safety and performance were evaluated through a series of lab bench tests to demonstrate compliance with recognized international standards and FDA guidance for TENS devices. These tests included:
- Electrical safety tests: Performed according to IEC 60601-1, IEC 60601-1-11, and IEC 60601-2-10 standards.
- Electromagnetic compatibility (EMC) tests: Performed according to IEC 60601-1-2 standard.
- Biocompatibility tests: Performed according to ISO 10993-1, ISO 10993-5, and ISO 10993-10 standards for the electrode pads.
- Usability tests: Performed according to IEC 62366-1 standard.
- Software verification and validation tests: Performed according to FDA "Guidance for Pre-Market Submissions and for Software Contained in Medical Devices."
- Waveform test report: Conducted to verify the output specifications of the device according to relevant FDA guidance documents for TENS and Powered Muscle Stimulators.
The document asserts that these tests, along with a detailed comparison of technological characteristics, features, specifications, materials, mode of operation, and intended use against three legally marketed predicate devices, demonstrate that the subject device is Substantially Equivalent (SE) to the primary predicate device. The differences noted (e.g., in number of output modes, maximum output voltage/current, pulse duration, pulse frequency) were concluded not to raise new issues of safety or effectiveness, as they either fell within acceptable ranges or aligned with existing requirements.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 19, 2020
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, Guangdong 51006 China
Re: K200237
Trade/Device Name: Transcutaneous Electronic Nerve Stimulator Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH Dated: July 15, 2020 Received: July 21, 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.
{1}------------------------------------------------
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, MS. Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K200237
Device Name
(Model: KTR-2401, KTR-2412, KTR-2412, KTR-2412, KTR-2302, KTR-2341, KTR-2342, KTR-2491, KTR-2492, KTR-2493, KTR-2494)
Indications for Use (Describe)
Transcutaneous Electronic Nerve Stimulator is indicated for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
| Sponsor: | Shenzhen Kentro Medical Electronics Co., Ltd |
|---|---|
| Subject Device: | Transcutaneous Electronic Nerve Stimulator, Model: KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2491, KTR-2492, KTR-2493, KTR-2494 |
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.
Submitter's Information 1.
- 510(k) Owner's Name: Shenzhen Kentro Medical Electronics Co., Ltd �
- Establishment Registration Number: 3013671142 �
- Address: No.3, Xihu industry zone, Xikeng Village, Henggang Town, Longgang District, Shenzhen, � Guangdong, China
- Tel: +86-755-33825998 �
- Fax: +86-755-33825996 �
- Contact Person: Zewu Zhang �
- � Email: kentro@kentro.com.cn
Application Correspondent: 2.
- � 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
- Transcutaneous Electronic Nerve Stimulator � Trade Name:
- KTR-2401. KTR-2402. KTR-2411. KTR-2412. KTR-2301. KTR-2302, KTR-2341, KTR-2342, KTR-2491, KTR-2492, � Model: KTR-2493, KTR-2494 Electronic Stimulator � Common Name:
- Stimulator, Nerve, Transcutaneous, Muscle, Powered, For Classification name: � Muscle Conditioning, Over-The-Counter Neurology, Physical Medicine
- Review Panel: �
- NUH Product Code: �
- ll � Regulation Class:
- 890.5850 � Regulation Number:
4. Predicate Device Information
| Sponsor | M.I.TECH Co., Ltd. | Shenzhen Kentro MedicalElectronics Co., Ltd | Guangzhou XinboElectronic Co., Ltd. |
|---|---|---|---|
| Device Nameand Model | HANAROCare ReJu | Transcutaneous ElectricalNerve StimulatorModel:KTR-206, KTR-208,KTR-209 | Pain Therapy DeviceModel: P.T.S-II, P.T.S-IIA,P.T.S-IIB, CP-I |
{4}------------------------------------------------
Shenzhen Kentro Medical Electronics Co., Ltd Sponsor:
Transcutaneous Electronic Nerve Stimulator, Model: KTR-2401, KTR-2402, KTR-2411. KTR-2412. KTR-2301. KTR-2302. KTR-2341. KTR-2342. KTR-2491. Subject Device: KTR-2492, KTR-2493, KTR-2494
| 510(k) Number | K160893 (Primary) | K183288 | K163611 |
|---|---|---|---|
| Product Code | NUH | NUH, NGX, NYN | NUH, NGX, NYN |
| Regulation Number | 882.5890 | 882.5890 | 882.5890 |
| Regulation Class | II | II | II |
5. Device Description
Transcutaneous Electronic Nerve Stimulator (Models:
KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2491, KTR-2492, KTR-2493, KTR-2494) is a portable and battery powered multifunctional device, offering Transcutaneous Electronic Nerve Stimulator. They can give certain electrical pulse through electrode pads placed on the skin to help users to enjoy body stimulation.
For models: KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2301, KTR-2302, KTR-2342 have 3 operation modes:
For models: KTR-2491, KTR-2493, KTR-2493, KTR-2494 have 15 operation modes, 9 manual mode, and 6 automatic mode. They can be remotely controlled with an accessory remote control. And there is a LCD displays on remote control, which display mode and treatment time.
The electronic stimulator module has unified the operating elements of ON/OFF button. Intensity adjust button and Mode selection button.
The device is equipped with accessories of electrode pads, batteries and remote control (For KTR-249X series).
The electrode pads are complying with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization), are interchangeable.
6. Intended Use / Indications for Use
Transcutaneous Electronic Nerve Stimulator is indicated for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
7. Test Summary
Transcutaneous Electronic Nerve Stimulator has been evaluated the safety and performance by lab bench testing as following:
- Electrical safety test according to IEC 60601-1. IEC 60601-1-11 and IEC 60601-2-10 standards �
- � Electromagnetic compatibility test according to IEC 60601-1-2 standard
- � Biocompatibility test according to ISO 10993-1, ISO 10993-5 and ISO 10993-10 standards
- 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"
{5}------------------------------------------------
| Sponsor: | Shenzhen Kentro Medical Electronics Co., Ltd |
|---|---|
| Transcutaneous Electronic Nerve Stimulator, Model: KTR-2401, KTR-2402, KTR- | |
| Subject Device: | 2411, KTR-2412, KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2491,KTR-2492, KTR-2493, KTR-2494 |
- ◆ The waveform test report has also been conducted to verify the output specifications of the device according to Guidance for Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use and Guidance for Powered Muscle Stimulator for Muscle Conditioning
8. Comparison to predicate device and conclusion
The technological characteristics, features, specifications, materials, mode of operation, and intended use of Transcutaneous Electronic Nerve Stimulator is substantially equivalent to the primary predicate device quoted above.
The differences between the subject device and primary predicate device do not raise new issues of safety or effectiveness.
| ElementsofComparison | Subject Device | Predicate Device 1(primary) | Predicate Device 2 | Predicate Device 3 | Remark |
|---|---|---|---|---|---|
| DeviceName andModel | TranscutaneousElectronic NerveStimulatorModel:KTR-2401,KTR-2402,KTR-2411,KTR-2412,KTR-2301,KTR-2302,KTR-2341,KTR-2342,KTR-2491,KTR-2492,KTR-2493,KTR-2494 | HANAROCare ReJu | TranscutaneousElectrical NerveStimulatorModel: KTR-206,KTR-208, KTR-209 | Pain TherapyDevice, Models:P.T.S-II, P.T.S-IIA,P.T.S-IIB, CP-I | -- |
| 510(k)Number | Applying | K160893 | K183288 | K163611 | -- |
| Productcode | NUH | NUH | NUH, NGX, NYN | NUH, NGX, NYN | SE |
| IntendedUse | TranscutaneousElectronic NerveStimulator isindicated fortemporary relief ofpain associated withsore and achingmuscles in theshoulder, waist, back,neck, upperextremities (arm) andlower extremities(leg) due to strainfrom exercise ornormal householdwork activities. | HANAROCare ReJuis indicated fortemporary relief ofpain associated withsore and achingmuscles in theshoulder, waist,back, neck, upperextremities (arm)and lowerextremities (leg) dueto strain fromexercise or normalhousehold workactivities. | To be used fortemporary relief ofpain associated withsore and achingmuscles in theshoulder, back,arm, leg, foot, dueto strain fromexercise or normalhousehold and workactivities. | To be used fortemporary relief ofpain associated withsore and achingmuscles in theupper and lowerback, back of theneck, upperextremities(shoulder and arm),lower extremities(leg and feet) due tostrain from exerciseor normalhousehold workactivities byapplying current tostimulate nerve.To be used forsymptomatic reliefand management of | SE |
| ElementsofComparison | Subject Device | Predicate Device 1(primary) | Predicate Device 2 | Predicate Device 3 | Remark |
| chronic, intractable pain and relief of pain associated with arthritis (Choose Mode B or C).To stimulate healthy muscles in order to improve and facilitate muscle performance (Choose Mode A).To temporarily increase local blood | |||||
| PowerSource(s) | For KTR-23XX series: CR2032;3Vdc; 240mAhFor KTR-24XX series: PL301526;3.7Vdc, 250mAh | Lithium-polymer, 3.7V | KTR-206: 2 AAA batteries (DC3V) | DC 3.0V, 2 x AAA | SENote 1 |
| PatientLeakageCurrent | NC DC: 0.5µA | DC: 0.5µA | DC: 0.5µA | ||
| SFC DC: 0.6μΑ | DC: 0.6μΑ | N/A (Battery operated) | DC: 0.6μΑ | SE | |
| Average DC current through electrodes when device is on but no pulses are being applied | < 0.01μΑ | < 0.01μΑ | -- | < 0.01μΑ | SE |
| Number of Output Channels: | 1 channel | 1 channel | 2 channels | 2 channels | SE |
| Number of Output Modes | For KTR-23XX series: 3 modesFor KTR-240X series | 4 | 5 | 3 | SENote 2 |
| Elements ofComparison | Subject Device | Predicate Device 1(primary) | Predicate Device 2 | Predicate Device 3 | Remark |
| & KTR-241X series: 3modesFor KTR-249X series:15 modes | |||||
| OutputIntensityLevel | 16 steps | 15steps | 16 steps | 5 steps | SE |
| Synchronous orAlternating? | Synchronous | Unknown | Synchronous | Synchronous | SE |
| RegulatedCurrent orRegulatedVoltage? | Voltage Control | Unknown | Voltage Control | Voltage Control | SE |
| Software/Firmware/MicroprocessorControl? | Yes | Yes | Yes | Yes | SE |
| AutomaticOverloadTrip | No | Unknown | No | No | SE |
| AutomaticNo-LoadTrip | No | Unknown | No | No | SE |
| AutomaticShut Off | Yes | Unknown | Yes | Yes | SE |
| UserOverrideControl | Yes | Unknown | Yes | Yes | SE |
| On/OffStatus | Yes | Unknown | Yes | Yes | SE |
| IndicatorLowBattery | No | Unknown | No | No | SE |
| DisplayVoltage/CurrentLevel | Yes | Unknown | Yes | Yes | SE |
| ElementsofComparison | Subject Device | Predicate Device 1(primary) | Predicate Device 2 | Predicate Device 3 | Remarks |
| TimerRange | 15min | 20 minutes fixed | 25min15min defaultKTR-206:5/10/15minKTR-208:5/10/15/20/25/30 minKTR-209:5/10/15/20/25/30 min | 10, 20, 40 min | SE |
| Weight | Main Unit:31gElectrode:EPAD-H01: 13g,EPAD-H02: 13g,EPAD-F01:15g,EPAD-F02: 10g,EPAD-F03: 12g,EPAD-B01: 8g,EPAD-T01: 8g,EPAD-Z01: 55g | 11g | KTR-206: 1.68ozKTR-208: 1.79ozKTR-209: 2.70oz | Main Unit:P.T.S-II: 75gP.T.S-IIA: 100gP.T.S-IIB: 100gCP-I: 66gElectrode:Big PatchElectrode: 40gSmall PatchElectrode:10gInsole Electrode:200gSole PlantElectrode A (onlyfor CP-I): 900gSole PlantElectrode B: 920g | SENote 1 |
| Dimensions of mainunit (mm) | Model KTR-2401:Φ46.3x12.07;Model KTR-2402:Φ46.28x11.69Model KTR-2411:46.29x46.29x12.08;Model KTR-2412:46.29x46.29x11.59;Model KTR-2301:Φ49.8x12.44;Model KTR-2302:Φ49.8x12.48Model KTR-2341:48.8x48.8x12.42;Model KTR-2342:48.8x48.8x12.45; | 36 x 35 x 13.7 mm | KTR-206:112.5x59x33.3mmKTR-208:112.5x59x29.5mm | Main Unit:P.T.S-II: 110 x 78 x 20 mmP.T.S-IIA: 135 x 82 x 20 mmP.T.S-IIB: 135 x 82 x 20 mmCP-I: 92 x 78 x 20 mmElectrode:Large PatchElectrode: 120 x 80 mmSmall PatchElectrode: 46 x 46 mmInsole Electrode:260 x 110 mmSole Plant | SENote 1 |
| ElementsofComparison | Subject Device | Predicate Device 1(primary) | Predicate Device 2 | Predicate Device 3 | Remarks |
| Model KTR-2491:Φ49.8x12.44;Model KTR-2492:Φ49.8x12.48Model KTR-2493:48.8x48.8x12.42;Model KTR-2494:48.8x48.8x12.45; | KTR-209:129.7x60x17.8mm | ElectrodeA (only for CP-I):450 x 450 x 90 mmSole PlantElectrode B: 450 x450 x 90 mm | |||
| HousingMaterialsandConstruction | Main unit: ABS plastic | RetardantPolycarbonate | Main unit: ABSplastic | Main unit: ABSplastic | SE |
| Waveform | Pulsed, symmetric,biphasic | Monophasic | Pulsed, symmetric,biphasic | Pulsed, symmetric,biphasic | SE |
| Shape | Rectangular, withinterphase interval | Rectangular | Rectangular, withinterphase interval | Rectangular | SE |
| 43.6V±10% @ 500Ω | (±10%) @ 500Ω• Mode 1: 64V• Mode 2: 67V• Mode 3: 59V• Combination : Thismode cycles theabove modes | KTR-206:49.6V@ 500Ω68.5V @ 2kΩ73V @ 10kΩ | 40V±10% @ 500Ω | ||
| MaximumOutputVoltage | 59V±10% @ 2KΩ | (±10%) @ 2KΩ• Mode 1: 113 V• Mode 2: 119 V• Mode 3: 108 V• Combination: Thismode cycles theabove modes. | KTR-208:58.5V @ 500Ω70V @ 2kΩ70.5V @ 10kΩ | 80V±10% @ 2KΩ | SENote 2 |
| 66.5V±10% @ 10KΩ | (±10%) @ 10KΩ<15 | KTR-209:62V @ 500Ω80V @ 2KΩ84V @ 10KΩ | 95V±10% @ 10KΩ | ||
| MaximumOutputCurrent | 87.2mA±10% @500Ω | (±10%) @ 500Ω• Mode 1 : 128 mA• Mode 2 : 134 mA• Mode 3 : 118 mA• Combination: Thismode cycles theabove modes. | KTR-206:99.2mA @ 500Ω34.25mA @ 2KΩ7.3mA @ 10KΩ | 80mA±10% @500Ω | SENote 2 |
| 29.5mA±10% @ 2KΩ | (±10%) @ 2KΩ• Mode 1: 57 mA | KTR-208:117mA @ 500Ω | 40mA±10% @ 2KΩ | ||
| ElementsofComparison | Subject Device | Predicate Device 1(primary) | Predicate Device 2 | Predicate Device 3 | Remark |
| • Mode 2: 60 mA• Mode 3: 54 mA• Combination: Thismode cycles theabove modes. | 35mA @ 2KΩ7.05mA @ 10KΩ | ||||
| 6.65mA±10% @10KΩ | (±10%) @ 10KΩ<15 | KTR-209:124mA @ 500Ω40mA @ 2KΩ8.4mA @ 10KΩ | 9.5mA±10%@10KΩ | ||
| PulseDuration | 120µs | (±10%)• Mode 1: 115 µs• Mode 2: 75 µs• Mode 3: 65 µs• Combination: Thismode cycles theabove modes. | KTR-206: 84µs-134µsKTR-208: 82µs-128µsKTR-209: 80µs-224µs | 200µs | SENote 2 |
| Pulsefrequency | 20-100Hz | (±10%)• Mode 1: 2Hz• Mode 2: 16.7Hz• Mode 3: 33.3Hz• Combination: Thismode cycles theabove modes. | KTR-206: 1Hz-108HzKTR-208: 1Hz-109HzKTR-209: 1Hz-110Hz | 13.7~48.5Hz | SENote 2 |
| NetCharge(perpulse) | 0µC @ 500Ω,Method: Balancedwaveform | Unknown | 0µC @ 500Ω,Method: Balancedwaveform | 0µC @ 500Ω,Method: Balancedwaveform | SE |
| MaximumPhaseCharge | 12.66µC @ 500Ω | (±10%) @ 500Ω• Mode 1: 14.72 µC• Mode 2: 10.05 µC• Mode 3: 7.67 µC• Combination: Thismode cycles theabove modes. | KTR-206: 12.32µC@ 500ΩKTR-208: 18.12µC@ 500ΩKTR-209: 33.07µC@ 500Ω | 19.3µC @ 500Ω | SENote 2 |
| MaximumCurrentDensity(mA/cm2,r.m.s.)(@500Ω) | 0.058 (mA/cm²) | (±10%)<StandardElectrode:12.57cm²>• Mode 1: 0.154• Mode 2: 0.377• Mode 3: 0.437• Combination: Thismode cycles the | KTR-206:0.26mA/cm²KTR-208:0.22mA/cm²KTR-209: 0.4mA/cm² | 0.073mA/cm² | SENote 2 |
| ElementsofComparison | Subject Device | Predicate Device 1(primary) | Predicate Device 2 | Predicate Device 3 | Remark |
| above modes.<Monarch Electrode:38.09 cm²>• Mode 1: 0.051• Mode 2: 0.124• Mode 3: 0.144• Combination: Thismode cycles theabove modes. | |||||
| MaximumAveragePowerDensity(@500Ω) | 0.037 (mW/cm²) | (±10%)<StandardElectrode:12.57cm²>• Mode 1: 0.15• Mode 2: 0.893• Mode 3:1.2• Combination: Thismode cycles theabove modes.<Monarch Electrode:38.09 cm²>• Mode 1: 0.049• Mode 2: 0.295• Mode 3: 0.396• Combination: Thismode cycles theabove | KTR-206: 0.001W/cm²KTR-208:0.0008W/cm²KTR-209:0.0025W/cm² | 0.056mW/cm² | SENote 2 |
| Environment foroperating | Environmenttemperature: +5°C-+40°C; Environmenthumidity: 0%-80%RH; Atmosphericenvironmentconditions: 860hPa-1060hPa. | Unknown | Environmenttemperature: +5°C-+40°C; Environmenthumidity: 0%-80%RH;Atmosphericenvironmentconditions: 860hPa-1060hPa. | Temperature:5 | SE |
| Environment forstorage | Environmenttemperature: 0°C-+55°C; Environmenthumidity: 0-93%RH;Atmosphericenvironmentconditions: 500hPa-1060hPa. | Unknown | Environmenttemperature: 0°C-+55°C; Environmenthumidity: 0-93%RH;Atmosphericenvironmentconditions: 500hPa-1060hPa. | Temperature:Main Unit: -20 | SE |
| Biocompa | All user directly | -ISO 10993-5: | All user directly | All user directly | SE |
| ElementsofComparisonon | Subject Device | Predicate Device 1(primary) | Predicate Device 2 | Predicate Device 3 | Remark |
| tibility | contacting materialsare compliance withISO10993-5 andISO10993-10requirements. | Cytotoxicity Test(Aggar DiffusionAssay)- ISO 10993-10:Primary skin irritationstudy in rabbits (4hour semi-occlusiveapplication)- ISO 10993-10:ContactHypersensitivity inAlbino Guiana PigsMaximization Test | contacting materialsare compliance withISO10993-5 andISO10993-10requirements. | contacting materialsare compliance withISO10993-5 andISO10993-10requirements. | |
| ElectricalSafety | Comply with IEC60601-1, IEC 60601-1-11 and IEC 60601-2-10 | Comply with IEC60601-1, IEC 60601-1-11 and IEC 60601-2-10 | Comply with IEC60601-1, IEC60601-1-11 and IEC60601-2-10 | Comply with IEC60601-1 and IEC60601-2-10 | SE |
| EMC | Comply with IEC60601-1-2 | Comply with IEC60601-1-2 | Comply with IEC60601-1-2 | Comply with IEC60601-1-2 | SE |
{6}------------------------------------------------
{7}------------------------------------------------
Sponsor: Shenzhen Kentro Medical Electronics Co., Ltd Transcutaneous Electronic Nerve Stimulator, Model: KTR-2401, KTR-2402, KTR-Subject Device: 2411, KTR-2412, KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2491, KTR-2492, KTR-2493, KTR-2494
{8}------------------------------------------------
{9}------------------------------------------------
{10}------------------------------------------------
Transcutaneous Electronic Nerve Stimulator, Model: KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2491, KTR-2492, KTR-2493, KTR-2494
Subject Device:
{11}------------------------------------------------
{12}------------------------------------------------
Shenzhen Kentro Medical Electronics Co., Ltd Sponsor:
Transcutaneous Electronic Nerve Stimulator, Model: KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2491, Subject Device: KTR-2492, KTR-2493, KTR-2494
Comparison in Detail(s):
Note 1:
Although the "Power source", "Weight" , "Dimensions of main unit (mm)" are a little different from the predicate device, but the differences will not raise any safety or effectiveness issue.
Note 2:
Although the "Number of Output Modes", "Maximum Output Voltage", "Maximum Output Current", "Pulse Duration", "Pulse frequency", "Maximum Phase Charge" "Maximum Average Current", "Maximum Current Density(r.m.s )" and "Maximum Average Power Density" of subject device are little different from the predicate device, their maximum peak voltage are very similar, and are all comply with IEC 60601-1 and IEC 60601-2-10 requirements. So the differences of the function specifications will not raise any safety or effectiveness issue.
Final Conclusion:
Based on the above analysis and tests performed, it can be concluded that the performance and function of the Transcutaneous Electronic Nerve Stimulator is Substantially Equivalent (SE) to the primary predicate device.
9. Date of the summary prepared: October 14, 2020
§ 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).