Transcutaneous Electronic Nerve Stimulator

K200237 · Shenzhen Kentro Medical Electronics Co., Ltd. · NUH · Oct 19, 2020 · Neurology

Device Facts

• Record ID: K200237
• Device Name: Transcutaneous Electronic Nerve Stimulator
• Applicant: Shenzhen Kentro Medical Electronics Co., Ltd.
• Product Code: NUH · Neurology
• Decision Date: Oct 19, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Portable, battery-powered transcutaneous electrical nerve stimulator (TENS) for OTC pain relief. Device delivers electrical pulses via skin-contact electrode pads to stimulate muscles. Models KTR-249X series include remote control with LCD for mode/time display; other models feature integrated buttons. Users operate device to select modes and adjust intensity. Output affects nerve/muscle stimulation to provide temporary pain relief. Device is intended for home use.

Clinical Evidence

Bench testing only. Evaluated for electrical safety (IEC 60601-1, IEC 60601-1-11, IEC 60601-2-10), electromagnetic compatibility (IEC 60601-1-2), biocompatibility (ISO 10993-1, 5, 10), usability (IEC 62366-1), and software verification/validation. Waveform testing verified output specifications against FDA guidance for TENS and powered muscle stimulators.

Technological Characteristics

Portable, battery-powered (CR2032 or Li-polymer) TENS device. ABS plastic housing. Pulsed, symmetric, biphasic waveform. 1 channel output. 3 to 15 operation modes. 16 intensity steps. Voltage-controlled. Biocompatible electrode pads (ISO 10993). Connectivity: optional remote control (KTR-249X series).

Indications for Use

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.

Regulatory Classification

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.

Predicate Devices

• HANAROCare ReJu (K160893)
• Transcutaneous Electrical Nerve Stimulator Model: KTR-206, KTR-208, KTR-209 (K183288)
• Pain Therapy Device Model: P.T.S-II, P.T.S-IIA, P.T.S-IIB, CP-I (K163611)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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

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# 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)

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| 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: [phone] �
- Fax: [phone] �
- Contact Person: Zewu Zhang �
- � Email: [e-mail]

#### 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: [phone]
- � Email: [e-mail]

#### 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 Medical<br>Electronics Co., Ltd | Guangzhou Xinbo<br>Electronic Co., Ltd. |
|--------------------------|--------------------|-------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Device Name<br>and Model | HANAROCare ReJu | Transcutaneous Electrical<br>Nerve Stimulator<br>Model:KTR-206, KTR-208,<br>KTR-209 | Pain Therapy Device<br>Model: P.T.S-II, P.T.S-IIA,<br>P.T.S-IIB, CP-I |

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#### 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"

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| 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,<br>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.

| Elements<br>of<br>Comparis<br>on | Subject Device | Predicate Device 1<br>(primary) | Predicate Device 2 | Predicate Device 3 | Remark |
|-----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Device<br>Name and<br>Model | Transcutaneous<br>Electronic Nerve<br>Stimulator<br>Model:<br>KTR-2401,KTR-2402,KTR-2411,KTR-<br>2412,KTR-2301,KTR-2302,KTR-2341,KTR-<br>2342,KTR-2491,KTR-2492,KTR-2493,KTR-<br>2494 | HANAROCare ReJu | Transcutaneous<br>Electrical Nerve<br>Stimulator<br>Model: KTR-206,<br>KTR-208, KTR-209 | Pain Therapy<br>Device, Models:<br>P.T.S-II, P.T.S-IIA,<br>P.T.S-IIB, CP-I | -- |
| 510(k)<br>Number | Applying | K160893 | K183288 | K163611 | -- |
| Product<br>code | NUH | NUH | NUH, NGX, NYN | NUH, NGX, NYN | SE |
| Intended<br>Use | Transcutaneous<br>Electronic Nerve<br>Stimulator is<br>indicated for<br>temporary relief of<br>pain associated with<br>sore and aching<br>muscles in the<br>shoulder, waist, back,<br>neck, upper<br>extremities (arm) and<br>lower extremities<br>(leg) due to strain<br>from exercise or<br>normal household<br>work activities. | HANAROCare ReJu<br>is indicated for<br>temporary relief of<br>pain associated with<br>sore and aching<br>muscles in the<br>shoulder, waist,<br>back, neck, upper<br>extremities (arm)<br>and lower<br>extremities (leg) due<br>to strain from<br>exercise or normal<br>household work<br>activities. | To be used for<br>temporary relief of<br>pain associated with<br>sore and aching<br>muscles in the<br>shoulder, back,<br>arm, leg, foot, due<br>to strain from<br>exercise or normal<br>household and work<br>activities. | To be used for<br>temporary relief of<br>pain associated with<br>sore and aching<br>muscles in the<br>upper and lower<br>back, back of the<br>neck, upper<br>extremities<br>(shoulder and arm),<br>lower extremities<br>(leg and feet) due to<br>strain from exercise<br>or normal<br>household work<br>activities by<br>applying current to<br>stimulate nerve.<br>To be used for<br>symptomatic relief<br>and management of | SE |
| Elements<br>of<br>Comparison | Subject Device | Predicate Device 1<br>(primary) | Predicate Device 2 | Predicate Device 3 | Remark |
| | | | | chronic, intractable pain and relief of pain associated with arthritis (Choose Mode B or C).<br>To stimulate healthy muscles in order to improve and facilitate muscle performance (Choose Mode A).<br>To temporarily increase local blood | |
| Power<br>Source(s) | For KTR-23XX series: CR2032;<br>3Vdc; 240mAh<br>For KTR-24XX series: PL301526;<br>3.7Vdc, 250mAh | Lithium-polymer, 3.7V | KTR-206: 2 AAA batteries (DC3V) | DC 3.0V, 2 x AAA | SE<br>Note 1 |
| Patient<br>Leakage<br>Current | 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 modes<br>For KTR-240X series | 4 | 5 | 3 | SE<br>Note 2 |
| Elements of<br>Comparison | Subject Device | Predicate Device 1<br>(primary) | Predicate Device 2 | Predicate Device 3 | Remark |
| | & KTR-241X series: 3<br>modes<br>For KTR-249X series:<br>15 modes | | | | |
| Output<br>Intensity<br>Level | 16 steps | 15steps | 16 steps | 5 steps | SE |
| Synchronous or<br>Alternating? | Synchronous | Unknown | Synchronous | Synchronous | SE |
| Regulated<br>Current or<br>Regulated<br>Voltage? | Voltage Control | Unknown | Voltage Control | Voltage Control | SE |
| Software/<br>Firmware/<br>Microprocessor<br>Control? | Yes | Yes | Yes | Yes | SE |
| Automatic<br>Overload<br>Trip | No | Unknown | No | No | SE |
| Automatic<br>No-Load<br>Trip | No | Unknown | No | No | SE |
| Automatic<br>Shut Off | Yes | Unknown | Yes | Yes | SE |
| User<br>Override<br>Control | Yes | Unknown | Yes | Yes | SE |
| On/Off<br>Status | Yes | Unknown | Yes | Yes | SE |
| Indicator<br>Low<br>Battery | No | Unknown | No | No | SE |
| Display<br>Voltage/<br>Current<br>Level | Yes | Unknown | Yes | Yes | SE |
| Elements<br>of<br>Comparison | Subject Device | Predicate Device 1<br>(primary) | Predicate Device 2 | Predicate Device 3 | Remarks |
| Timer<br>Range | 15min | 20 minutes fixed | 25min15min default<br>KTR-<br>206:5/10/15min<br>KTR-<br>208:5/10/15/20/25/30 min<br>KTR-<br>209:5/10/15/20/25/30 min | 10, 20, 40 min | SE |
| Weight | Main Unit:31g<br>Electrode:<br>EPAD-H01: 13g,<br>EPAD-H02: 13g,<br>EPAD-F01:15g,<br>EPAD-F02: 10g,<br>EPAD-F03: 12g,<br>EPAD-B01: 8g,<br>EPAD-T01: 8g,<br>EPAD-Z01: 55g | 11g | KTR-206: 1.68oz<br>KTR-208: 1.79oz<br>KTR-209: 2.70oz | Main Unit:<br>P.T.S-II: 75g<br>P.T.S-IIA: 100g<br>P.T.S-IIB: 100g<br>CP-I: 66g<br>Electrode:<br>Big Patch<br>Electrode: 40g<br>Small Patch<br>Electrode:10g<br>Insole Electrode:<br>200g<br>Sole Plant<br>Electrode A (only<br>for CP-I): 900g<br>Sole Plant<br>Electrode B: 920g | SE<br>Note 1 |
| Dimensions of main<br>unit (mm) | Model KTR-2401:<br>Φ46.3x12.07;<br>Model KTR-2402:<br>Φ46.28x11.69<br>Model KTR-2411:<br>46.29x46.29x12.08;<br>Model KTR-2412:<br>46.29x46.29x11.59;<br>Model KTR-2301:<br>Φ49.8x12.44;<br>Model KTR-2302:<br>Φ49.8x12.48<br>Model KTR-2341:<br>48.8x48.8x12.42;<br>Model KTR-2342:<br>48.8x48.8x12.45; | 36 x 35 x 13.7 mm | KTR-206:<br>112.5x59x33.3mm<br>KTR-208:<br>112.5x59x29.5mm | Main Unit:<br>P.T.S-II: 110 x 78 x 20 mm<br>P.T.S-IIA: 135 x 82 x 20 mm<br>P.T.S-IIB: 135 x 82 x 20 mm<br>CP-I: 92 x 78 x 20 mm<br>Electrode:<br>Large Patch<br>Electrode: 120 x 80 mm<br>Small Patch<br>Electrode: 46 x 46 mm<br>Insole Electrode:<br>260 x 110 mm<br>Sole Plant | SE<br>Note 1 |
| Elements<br>of<br>Comparison | Subject Device | Predicate Device 1<br>(primary) | Predicate Device 2 | Predicate Device 3 | Remarks |
| | Model KTR-2491:<br>Φ49.8x12.44;<br>Model KTR-2492:<br>Φ49.8x12.48<br>Model KTR-2493:<br>48.8x48.8x12.42;<br>Model KTR-2494:<br>48.8x48.8x12.45; | | KTR-209:<br>129.7x60x17.<br>8mm | Electrode<br>A (only for CP-I):<br>450 x 450 x 90 mm<br>Sole Plant<br>Electrode B: 450 x<br>450 x 90 mm | |
| Housing<br>Materials<br>and<br>Construction | Main unit: ABS plastic | Retardant<br>Polycarbonate | Main unit: ABS<br>plastic | Main unit: ABS<br>plastic | SE |
| Waveform | Pulsed, symmetric,<br>biphasic | Monophasic | Pulsed, symmetric,<br>biphasic | Pulsed, symmetric,<br>biphasic | SE |
| Shape | Rectangular, with<br>interphase interval | Rectangular | Rectangular, with<br>interphase interval | Rectangular | SE |
| | 43.6V±10% @ 500Ω | (±10%) @ 500Ω<br>• Mode 1: 64V<br>• Mode 2: 67V<br>• Mode 3: 59V<br>• Combination : This<br>mode cycles the<br>above modes | KTR-206:<br>49.6V@ 500Ω<br>68.5V @ 2kΩ<br>73V @ 10kΩ | 40V±10% @ 500Ω | |
| Maximum<br>Output<br>Voltage | 59V±10% @ 2KΩ | (±10%) @ 2KΩ<br>• Mode 1: 113 V<br>• Mode 2: 119 V<br>• Mode 3: 108 V<br>• Combination: This<br>mode cycles the<br>above modes. | KTR-208:<br>58.5V @ 500Ω<br>70V @ 2kΩ<br>70.5V @ 10kΩ | 80V±10% @ 2KΩ | SE<br>Note 2 |
| | 66.5V±10% @ 10KΩ | (±10%) @ 10KΩ<br><15 | KTR-209:<br>62V @ 500Ω<br>80V @ 2KΩ<br>84V @ 10KΩ | 95V±10% @ 10KΩ | |
| Maximum<br>Output<br>Current | 87.2mA±10% @<br>500Ω | (±10%) @ 500Ω<br>• Mode 1 : 128 mA<br>• Mode 2 : 134 mA<br>• Mode 3 : 118 mA<br>• Combination: This<br>mode cycles the<br>above modes. | KTR-206:<br>99.2mA @ 500Ω<br>34.25mA @ 2KΩ<br>7.3mA @ 10KΩ | 80mA±10% @<br>500Ω | SE<br>Note 2 |
| | 29.5mA±10% @ 2KΩ | (±10%) @ 2KΩ<br>• Mode 1: 57 mA | KTR-208:<br>117mA @ 500Ω | 40mA±10% @ 2KΩ | |
| Elements<br>of<br>Comparis<br>on | Subject Device | Predicate Device 1<br>(primary) | Predicate Device 2 | Predicate Device 3 | Remark |
| | | • Mode 2: 60 mA<br>• Mode 3: 54 mA<br>• Combination: This<br>mode cycles the<br>above modes. | 35mA @ 2KΩ<br>7.05mA @ 10KΩ | | |
| | 6.65mA±10% @<br>10KΩ | (±10%) @ 10KΩ<br><15 | KTR-209:<br>124mA @ 500Ω<br>40mA @ 2KΩ<br>8.4mA @ 10KΩ | 9.5mA±10%<br>@10KΩ | |
| Pulse<br>Duration | 120µs | (±10%)<br>• Mode 1: 115 µs<br>• Mode 2: 75 µs<br>• Mode 3: 65 µs<br>• Combination: This<br>mode cycles the<br>above modes. | KTR-206: 84µs-<br>134µs<br>KTR-208: 82µs-<br>128µs<br>KTR-209: 80µs-<br>224µs | 200µs | SE<br>Note 2 |
| Pulse<br>frequency | 20-100Hz | (±10%)<br>• Mode 1: 2Hz<br>• Mode 2: 16.7Hz<br>• Mode 3: 33.3Hz<br>• Combination: This<br>mode cycles the<br>above modes. | KTR-206: 1Hz-<br>108Hz<br>KTR-208: 1Hz-<br>109Hz<br>KTR-209: 1Hz-<br>110Hz | 13.7~48.5Hz | SE<br>Note 2 |
| Net<br>Charge<br>(per<br>pulse) | 0µC @ 500Ω,<br>Method: Balanced<br>waveform | Unknown | 0µC @ 500Ω,<br>Method: Balanced<br>waveform | 0µC @ 500Ω,<br>Method: Balanced<br>waveform | SE |
| Maximum<br>Phase<br>Charge | 12.66µC @ 500Ω | (±10%) @ 500Ω<br>• Mode 1: 14.72 µC<br>• Mode 2: 10.05 µC<br>• Mode 3: 7.67 µC<br>• Combination: This<br>mode cycles the<br>above modes. | KTR-206: 12.32µC<br>@ 500Ω<br>KTR-208: 18.12µC<br>@ 500Ω<br>KTR-209: 33.07µC<br>@ 500Ω | 19.3µC @ 500Ω | SE<br>Note 2 |
| Maximum<br>Current<br>Density(m<br>A/cm2,<br>r.m.s.)<br>(@500Ω) | 0.058 (mA/cm²) | (±10%)<br><Standard<br>Electrode:<br>12.57cm²><br>• Mode 1: 0.154<br>• Mode…