Low-frequency Multi-function physiotherapy instrument

{0}------------------------------------------------ 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. {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 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 {2}------------------------------------------------ # 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. 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. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------|-----------------------------------------------------------| | <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) | # CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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}------------------------------------------------ ## 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 Medical<br>Electronics Co., Ltd | Guangzhou Xinbo<br>Electronic Co., Ltd. | Shenzhen OSTO<br>Technology Co., Ltd. | |--------------------------|----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|------------------------------------------------------------------------------------| | Device Name and<br>Model | KTR-2230, KTR-2220, KTR-<br>2210, KTR-2231, KTR-2221,<br>KTR-2211, KTR-2232, KTR-<br>2222, KTR2212 | Pain Therapy Device<br>Models: P.T.S-II, P.T.S-<br>IIA, P.T.S-IIB, CP-I | Intelligent Wireless<br>Fitness Apparatus<br>Models: AST-301, AST-<br>302, AST-303 | | 510(k) Number | K191982 | K163611 | K182136 | | Product Code | NUH, NGX | NUH, NGX, NYN | NGX | {4}------------------------------------------------ | Regulation Number | 882.5890, 890.5850 | 882.5890, 890.5850 | 890.5850 | |------------------------------|--------------------------|--------------------|------------------| | Regulation Class | II | II | II | | Primary/ Reference<br>device | 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 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 1~20) 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 21~40) 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. {5}------------------------------------------------ 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. {6}------------------------------------------------ | Elements of Comparison | Subject Device | Predicate Device 1<br>(Primary predicate<br>device) | Predicate Device 2<br>(Reference Device) | Predicate Device 3<br>(Reference Device) | Remark | |-----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------| | Device Name and Model | Low-frequency Multi-<br>function physiotherapy<br>instrument<br>Model: KTR-2240,<br>KTR-2250, KTR-2241,<br>KTR-2251, KTR-2242,<br>KTR-2252, KTR-2610,<br>KTR-2640, KTR-2650,<br>KTR-2611, KTR-2641,<br>KTR-2651, KTR-2612,<br>KTR-2642, KTR-2652 | Low-frequency Multi-<br>function<br>physiotherapy<br>instrument<br>Model: KTR-2230,<br>KTR-2220, KTR-<br>2210, KTR-2231,<br>KTR-2221, KTR-<br>2211, KTR-2232,<br>KTR-2222, KTR-2212 | Pain Therapy Device,<br>Models: P.T.S-II,<br>P.T.S-IIA, P.T.S-IIB,<br>CP-I | Intelligent Wireless<br>Fitness Apparatus<br>Models: AST-301,<br>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,<br>KTR-2610, KTR-2640,<br>KTR-2650: (TENS,<br>EMS, FITNESS)<br>TENS (Mode 1~20):<br>To be used for temporary<br>relief of pain<br>associated with sore<br>and aching muscles in<br>the shoulder, waist,<br>back, back of the neck,<br>arm, leg, and foot due<br>to strain from exercise<br>or normal household<br>work activities by<br>applying current to<br>stimulate nerve.<br>EMS (Mode 21~40): It<br>is intended to stimulate<br>healthy muscles in<br>order to improve and | KTR-2210, KTR-<br>2220, KTR-2230:<br>(TENS, EMS,<br>FITNESS)<br>TENS (Mode 1~20):<br>To be used for<br>temporary relief of<br>pain associated with<br>sore and aching<br>muscles in the<br>shoulder, waist, back,<br>back of the neck, arm,<br>leg, and foot due to<br>strain from exercise<br>or normal household<br>work activities by<br>applying current to<br>stimulate nerve.<br>EMS (Mode 21~40): It<br>is intended to<br>stimulate healthy | To be used for<br>temporary relief of<br>pain associated with<br>sore and aching<br>muscles in the upper<br>and lower back, back<br>of the neck, upper<br>extremities (shoulder<br>and arm), lower<br>extremities (leg and<br>feet) due to strain from<br>exercise or normal<br>household work<br>activities by applying<br>current to stimulate<br>nerve.<br>To be used for<br>symptomatic relief and<br>management of<br>chronic, intractable<br>pain and relief of pain | Intelligent Wireless<br>Fitness Apparatus is<br>indicated to be used<br>for: Improvement of<br>abdominal tone,<br>strengthening of the<br>abdominal muscles<br>development of firmer<br>abdomen.<br>Strengthening, toning<br>and firming of buttocks<br>and thighs. | SE | | Elements of Comparison | Subject Device | Predicate Device 1<br>(Primary predicate<br>device) | Predicate Device 2<br>(Reference Device) | Predicate Device 3<br>(Reference Device) | Remark | | Power Source(s) | facilitate muscle<br>performance.<br>FITNESS (Mode<br>41~50): Improvement<br>of abdominal tone,<br>strengthening of the<br>abdominal muscle<br>development of firmer<br>abdomen.<br>KTR-2241, KTR-2251,<br>KTR-2242, KTR-2252,<br>KTR-2611, KTR-2641,<br>KTR-2651, KTR-2612,<br>KTR-2642, KTR-2652:<br>(TENS)<br>To be used for<br>temporary relief of pain<br>associated with sore<br>and aching muscles in<br>the shoulder, waist,<br>back, back of the neck,<br>arm, leg, and foot due<br>to strain from exercise<br>or normal household<br>work activities by<br>applying current to<br>stimulate nerve. | muscles in order to<br>improve and facilitate<br>muscle performance.<br>FITNESS (Mode<br>41~50): Improvement<br>of abdominal tone,<br>strengthening of the<br>abdominal muscles<br>development of firmer<br>abdomen.<br>KTR-2211, KTR-<br>2221, KTR-2231,<br>KTR-2212, KTR-<br>2222, KTR-2232:<br>(TENS)<br>To be used for<br>temporary relief of<br>pain associated with<br>sore and aching<br>muscles in the<br>shoulder, waist, back,<br>back of the neck, arm,<br>leg, and foot due to<br>strain from exercise<br>or normal household<br>work activities by<br>applying current to<br>stimulate nerve. | associated with<br>arthritis (Choose Mode<br>B or C).<br>To stimulate healthy<br>muscles in order to<br>improve and facilitate<br>muscle performance<br>(Choose Mode A).<br>To temporarily<br>increase local blood. | | | | Power Source(s) | For model KTR-2240,<br>KTR-2250, KTR-2241,<br>KTR-2251, KTR-2242,<br>KTR-2252: DC 4.5V<br>(3xAAA LR03 battery),<br>180mA<br>For model KTR-2610 | DC 4.5V (3*AAA<br>LR03 battery), 180mA | DC 3.0V, 2 x AAA | Adapter (Model<br>HDMU05E-050100,<br>HDMU05B-050100,<br>HDMU05U-050100)<br>Input: 100-240 Vac;<br>50/60 Hz; 0,3A;<br>Output: 5 V; 1A | SE | | Elements of Comparison | Subject Device | Predicate Device 1<br>(Primary predicate<br>device) | Predicate Device 2<br>(Reference Device) | Predicate Device 3<br>(Reference Device) | Remark | | | KTR-2640, KTR-2650,<br>KTR-2611, KTR-2641,<br>KTR-2651, KTR-2612,<br>KTR-2642, KTR-2652:<br>3.7V/250mAh lithium<br>battery | | | Rechargeable Lithium-<br>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 Leakage<br>Current | 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 through<br>electrodes when device is on but no<br>pulses are being applied | < 0.01μA | < 0.01μA | < 0.01 | Not publicly available | SE | | Number of Output Channels: | 2 channels | 2 channels | 2 Channels: for<br>models P.T.S-II,<br>P.T.S-IIA, P.T.S-IIB;<br>1 Channel: for<br>model CP-I | 2 | SE | | Number of Output Modes | For model KTR-2240,<br>KTR-2250, KTR-2610,<br>KTR-2640, KTR-2650:<br>50 modes; | 50 | 3 | 8 | SE | {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ | | Elements of Comparison | Subject Device | Predicate Device 1<br>(Primary predicate<br>device) | Predicate Device 2<br>(Reference Device) | Predicate Device 3<br>(Reference Device) | Remark | | |--|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|------------------------------------------|--------------|----| | | | KTR-2251, KTR-2242,<br>KTR-2252, KTR-2611,<br>KTR-2641, KTR-2651,<br>KTR-2612, KTR-2642,<br>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 Transform<br>Isolation<br>"Ch1+" and "Ch1-"<br>buttons for channel 1,<br>"Ch2+" and "Ch2-"<br>buttons for channel 2 | Voltage Transform<br>Isolation<br>"Ch1+" and "Ch1-"<br>buttons for channel 1,<br>"Ch2+" and "Ch2-"<br>buttons for channel 2 | Parallel connection | Voltage Transform<br>Isolation | SE | | | | Regulated Current or Regulated<br>Voltage? | Voltage Control | Voltage Control | Regulated Voltage | Voltage Control | SE | | | | Software/Firmware/Microprocessor<br>Control? | 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/ Current<br>Level | 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,<br>KTR-2241, KTR-2242:<br>110g<br>For model KTR-2250 | KTR-2210, KTR-<br>2211, KTR-2212: 76g<br>KTR-2220, KTR-<br>2221, KTR-2222: 82g | Main Unit:<br>P.T.S-II: 75g<br>P.T.S-IIA: 100g | 80g (Without<br>accessories) | SE<br>Note 1 | | {10}------------------------------------------------ | Elements of Comparison | Subject Device | Predicate Device 1<br>(Primary predicate<br>device) | Predicate Device 2<br>(Reference Device) | Predicate Device 3<br>(Reference Device) | Remark | |------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------| | | KTR-2251, KTR-2252:<br>114g<br>For model KTR-2610,<br>KTR-2611, KTR-2612:<br>70g<br>For model KTR-2640,<br>KTR-2641, KTR-2642:<br>68g<br>For model KTR-2650,<br>KTR-2651, KTR-2652:<br>71g | KTR-2230, KTR-<br>2231, KTR-2232: 75g<br>Electrode :12g<br>Electrode wire: 12g | CP-I: 66g<br>Electrode:<br>Big Patch Electrode:<br>40g<br>Small Patch<br>Electrode:10g<br>Insole Electrode: 200g<br>Sole Plant Electrode A<br>(only for CP-I): 900g<br>Sole Plant Electrode B:<br>920g | | | | Dimensions | Main unit:<br>For model KTR-2240,<br>For model KTR-2240,<br>KTR-2241, KTR-2242:<br>122mm x 55mm x<br>21mm;<br>For model KTR-2250,<br>KTR-2251, KTR-2252:<br>122mm x 55mm x<br>21.6mm;<br>For model KTR-2610,<br>KTR-2611, KTR-2612:<br>122mm x 55mm x<br>15.7mm;<br>For model KTR-2640,<br>KTR-2641, KTR-2642:<br>122mm x 55mm x<br>14.9mm;<br>For model KTR-2650,<br>KTR-2651, KTR-2652:<br>122mm x 55mm x<br>15.5mm<br>Electrode Pads: 3<br>kinds | Main unit: KTR 2210,<br>KTR-2211, KTR-<br>2212: 122mm * 55mm<br>* 21.8mm;<br>KTR-2220, KTR-<br>2221, KTR-2222,<br>KTR-2230, KTR-2231<br>and KTR- 2232:<br>120mm * 55mm *<br>20.4mm<br>Electrode: Square<br>shape: 50mm x<br>50mm (Area: 25cm2)<br>Irregularly shape:<br>about 50mm x 70mm<br>(Area: about 30cm2) | Main Unit:<br>P.T.S-II: 110 x 78 x 20<br>mm<br>P.T.S-IIA: 135 x 82 x<br>20 mm<br>P.T.S-IIB: 135 x 82 x<br>20 mm<br>CP-I: 92 x 78 x 20<br>mm<br>Electrode:<br>Large Patch Electrode:<br>120 x 80 mm<br>Small Patch Electrode:<br>46 x 46<br>mm<br>Insole Electrode:<br>260 x 110 mm<br>Sole Plant Electrode<br>A (only for CP-I):<br>450 x 450 x 90 mm<br>Sole Plant Electrode B:<br>450 x 450 x 90 mm | Main Unit: 50X37mm<br>Electrode pad for<br>model AST-301:<br>198mm x 164mm x<br>2mm<br>Electrode pad for<br>model AST-302:<br>192mm x 164mm x<br>2mm<br>Electrode pad for<br>model AST-303: 125<br>mm x 80mm x 2mm<br>Each gel sheet 90mm x<br>60mm x2 mm | SE<br>Note 1 | | Elements of Comparison | Subject Device | Predicate Device 1<br>(Primary predicate<br>device) | Predicate Device 2<br>(Reference Device) | Predicate Device 3<br>(Reference Device) | Remark | | | EPAD-D01: 70x52mm<br>EPAD-D02: 50x50mm<br>EPAD-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,<br>biphasic | Pulsed, symmetric,<br>biphasic | Pulsed, symmetric,<br>biphasic | Pulsed, Symmetrical,<br>Biphasic | SE | | Shape | Rectangular, with<br>interphase interval | Rectangular, with<br>interphase interval | Rectangular, with<br>interphase interval | Rectangular, with<br>interphase<br>interval | 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 | SE<br>Note 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 | SE<br>Note 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:<br>200µs, FITNESS:<br>200µs…