HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. January 17, 2023 HillTek LLC % Bhoomika Joyappa Medical Device Academy Inc, 345 Lincoln Hill Road Shrewsbury, Vermont 05738 ### Re: K213655 Trade/Device Name: HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch) Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF, GZJ, LIH Dated: December 19, 2022 Received: December 20, 2022 ### Dear Bhoomika Joyappa: 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. 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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Heather L. Dean -S Heather Dean, PhD Assistant Director, Acute Injury Devices Team 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) K213655 ### Device Name HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch) Indications for Use (Describe) HiToP®4touch, HiToP®2touch, and HiToP®1touch is intended to be used as Powered muscle stimulator - Relaxation of muscle spasms - Increase local blood circulation - · Muscle re-education - · Maintaining or increasing range of motion ### TENS · Symptomatic relief and management of chronic, intractable pain Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) | 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}------------------------------------------------ # 510(k) SUMMARY K213655 This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92: #### l. SUBMITTER HillTek LLC 421 S Brookhurst Street; Ste#142 Anaheim, CA 92804, USA +1.206.406.9390 Contact Person: Mohammadali Nezakati Date Prepared: November 18, 2021 #### II. DEVICE | Name of Device: | HiToP® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch) | |------------------------------|-----------------------------------------------------------| | Classification Name: | Physical Medicine Devices and Neurology | | Regulation: | 21 CFR §890.5850 | | Regulatory Class: | Class II | | Product Classification Code: | IPF, GZJ, LIH | #### III. PRIMARY PREDICATE DEVICE - Predicate Manufacturer: Mettler Electronics Corp. - Predicate Trade Name: Sys*Stim 240 ● - . Predicate 510(k): K113017 No reference devices were used in this submission. #### IV. DEVICE DESCRIPTION The High Tone Power therapy (HiToP®) is a non-invasive electrical muscle stimulator/ powered muscle stimulator and Transcutaneous Electrical Nerve Stimulator (TENS). The device is designed for pain management, muscle strengthening, training, muscle relaxation, and re-education. The device stimulates the underlying muscle groups through electrical impulses transmitted via electrodes applied on the skin. The device can deliver medium frequency sinusoidal electrical waves with different programmable {4}------------------------------------------------ parameters such as frequency, duration of rest, and total session duration to underlying muscle groups. In High Tone power therapy, the amplitude and the frequency are modulated simultaneously. The High Tone Power Therapy devices (HiToP®) provide a therapy with medium frequency sine current waves ranging from 4096 – 32768 Hz. The amplitude (A) and frequency (f) of Sine waves can be simultaneously modulated, so this method is called SimulFAM® which stands for Simultaneous Frequency Amplitude Modulation. ### SimulFAM®X A frequency scan of three octaves is realized. The frequency scan is realized with different speed (0.1 - 200 Hz). There are three models of HiToP®, which are HiToP® touch, HiToP® 1 touch. Each model's intended use, working principle, product structure, and significant parameters are the slight difference in product appearance and number of programs. HiToP®4 touch, HiToP®2 touch, HiToP®1 touch is used at healthcare facilities and hospitals. The device's parameters are controlled by the driver (control knob), and the user can select the desired therapy using a graphical user interface. #### V. INDICATIONS FOR USE HiToP®4 touch, HiToP®2 touch, and HiToP®1 touch is intended to be used as Powered muscle stimulator - . Relaxation of muscle spasms - Increase local blood circulation . - Muscle re-education . - Maintaining or increasing range of motion ● ### TENS - Symptomatic relief and management of chronic, intractable pain ● #### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PRIMARY PREDICATE DEVCE The following characteristics were compared between the predicate device to demonstrate substantial equivalence: | Device | Subject device Model<br>HiToP®4 touch | Subject device Model<br>HiToP®2 touch | Subject device Model<br>HiToP®1 touch | Primary Predicate<br>Device<br>Sys*Stim 240 | SE comparison | |--------|---------------------------------------|---------------------------------------|---------------------------------------|---------------------------------------------|---------------| |--------|---------------------------------------|---------------------------------------|---------------------------------------|---------------------------------------------|---------------| {5}------------------------------------------------ | Submitter | HillTek LLC | HillTek LLC | HillTek LLC | Mettler Electronics<br>Corp | - | | Interferential Current<br>Therapy LIH | Interferential Current<br>Therapy LIH | Interferential Current<br>Therapy LIH | Interferential Current<br>Therapy LIH | Same | |------------------------|--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510K Number | K213655 | K213655 | K213655 | K113017 | - | | NA | NA | NA | Lamp, Infrared,<br>Therapeutic Heating<br>ILY | Different:<br>The subject device is<br>not a Lamp, Infrared,<br>Therapeutic Heating<br>device. Therefore,<br>product code ILY is not<br>applicable to the<br>subject device. This<br>eliminates the risks<br>associated with that<br>function | | Common or Usual Name | Transcutaneous<br>Electrical Nerve<br>Stimulator for pain<br>relief<br>Powered Muscle<br>Stimulator | Transcutaneous<br>Electrical Nerve<br>Stimulator for pain<br>relief<br>Powered Muscle<br>Stimulator | Transcutaneous<br>Electrical Nerve<br>Stimulator for pain<br>relief<br>Powered Muscle<br>Stimulator | Transcutaneous<br>Electrical Nerve<br>Stimulator for pain<br>relief<br>Powered Muscle<br>Stimulator | Same | Regulation Number | 21 CFR 890.5850 | 21 CFR 890.5850 | 21 CFR 890.5850 | 21 CFR 890.5850<br>21 CFR 890.5500 | Similar<br>21 CFR 890.5500 is<br>used for Lamp,<br>Infrared, Therapeutic<br>Heating device that is<br>not applicable to the<br>subject device. This<br>eliminates the risks<br>associated with that<br>function | | | NA | NA | NA | Infrared lamp | - | Indications for Use | Powered muscle<br>stimulator<br>• Relaxation of<br>muscle spasms<br>• Increase local<br>blood circulation<br>• Muscle re-<br>education<br>• Maintaining or<br>increasing range of<br>motion<br>TENS | Powered muscle<br>stimulator<br>• Relaxation of<br>muscle spasms<br>• Increase local<br>blood circulation<br>• Muscle re-<br>education<br>• Maintaining or<br>increasing range<br>of motion<br>TENS | Powered muscle<br>stimulator<br>• Relaxation of<br>muscle spasms<br>• Increase local<br>blood circulation<br>• Muscle re-<br>education<br>• Maintaining or<br>increasing range of<br>motion | Indications for<br>Medium Frequency<br>(Russian), Biphasic,<br>High Volt Pulsed<br>Current (HVPC),<br>Interferential (4P) and<br>Premodulated (2P3)<br>waveforms:<br>Relaxation of muscle<br>spasms<br>• Prevention or<br>retardation of<br>disuse atrophy | Similar:<br>The indication of use<br>is identical in both<br>subject device and<br>predicate devices. The<br>additional indications<br>for use i.e Indications<br>for DC (Direct Current)<br>Mode and the laser<br>and cluster applicators<br>in the predicate<br>devices is not<br>applicable for the | | Product Code | IPF, LIH, GZJ | IPF, LIH, GZJ | IPF, LIH, GZJ | IPF, ILY, GZJ, LIH | Similar<br>The subject device is<br>used for electrical<br>stimulation. It is not a<br>Lamp, Infrared,<br>Therapeutic Heating<br>device. Therefore,<br>product code ILY is not<br>applicable to the<br>subject device. This<br>eliminates the risks<br>associated with that<br>function | | | | | | | | Product Classification | Class II | Class II | Class II | Class II | Same | | | | | | | | Classification Name | Stimulator, nerve,<br>transcutaneous, for<br>pain relief (GZJ)<br>Stimulator, muscle,<br>powered (IPF) | Stimulator, nerve,<br>transcutaneous, for<br>pain relief (GZJ)<br>Stimulator, muscle,<br>powered (IPF) | Stimulator, nerve,<br>transcutaneous, for<br>pain relief (GZJ)<br>Stimulator, muscle,<br>powered (IPF) | Stimulator, nerve,<br>transcutaneous, for<br>pain relief (GZJ)<br>Stimulator, muscle,<br>powered (IPF) | Same | | | | | | | {6}------------------------------------------------ {7}------------------------------------------------ | Symptomatic relief and management of chronic, intractable pain | Symptomatic relief and management of chronic, intractable pain | TENS Symptomatic relief and management of chronic, intractable pain | Increase local blood circulation Muscle re-education Maintaining or increasing range of motion Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis Indications for Microcurrent, Interferential (4P3), Premodulated (2P), Biphasic, and TENS waveforms: Symptomatic relief and management of chronic, intractable pain Post-traumatic acute pain Post-surgical acute pain Indications for DC (Direct Current) Mode Relaxation of muscle spasm The laser and cluster | subject device as the subject device is not an Infrared, Therapeutic Heating device and does not work in DC mode | |----------------------------------------------------------------|----------------------------------------------------------------|----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------| |----------------------------------------------------------------|----------------------------------------------------------------|----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------| {8}------------------------------------------------ | Type of Use | Prescription (Rx Only) | Prescription (Rx Only) | Prescription (Rx Only) | Prescription (Rx Only) | Same<br>Different: | | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|---------------------------------------------------|---------------------------------------------------|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Power Source(s) | 100-240V~, 50-60 Hz,<br>200VA / AC Line | 100-240V~, 50-60 Hz,<br>120VA / AC Line | 100-240V~, 50-60 Hz,<br>45VA / AC Line | AC line or optional<br>battery pack 10.8 V AC<br>line or optional<br>battery pack Lithium<br>Ion | The subject device is<br>limited to use with AC<br>line as the power<br>source. The subject<br>device does not<br>include an optional<br>battery pack like the<br>predicate device, and<br>this does not<br>introduce any new<br>risks. The subject<br>device complies with<br>IEC 60601-1<br>requirements for<br>evaluation of safety.<br>These differences do | | | Sys*Stim 240 emit infrared energy for:<br>Temporary increase in local blood circulation Temporary relief of minor muscle and joint aches, pains and stiffness Relaxation of muscles Temporary relief of muscle spasms Temporary relief of minor pain and stiffness associated with arthritis | | | | | | | | | | | | | question of safety and<br>effectiveness | | | Method of Line Current Isolation | 2 MOPP | 2 MOPP | 2 MOPP | Yes, value unknown | Similar:<br>The subject device has<br>been tested for<br>electrical isolation<br>protection against<br>electric shock<br>according to standard<br>requirement IEC<br>IEC60601-1. Does not<br>raise any safety and<br>effectiveness concerns | | | Patient leakage current - normal<br>condition (μΑ) | 4.7 μΑ | 4.7 μΑ | 8.0 μΑ | 78 μΑ (Less than 100 μΑ) | Similar:<br>The subject device<br>demonstrated<br>electrical safety by<br>passing ANSI AAMI<br>ES60601-1 and IEC<br>60601-2-10 tests. The<br>difference does not<br>raise the issue of<br>product's safety and<br>effectiveness. | | | Patient leakage current - single<br>fault condition (μΑ) | 34μΑ<br>(AC SFC 264V 60 Hz) | 34μΑ<br>(AC SFC 264V 60 Hz) | 16.0μΑ<br>(AC SFC 264V 60 Hz) | 78 µA (Less than 500 μΑ) | | | | Number of Output Channels | 4 | 2 | 1 | 2 | The number of<br>channels of output<br>current do not affect<br>the treatment, and<br>the design of subject<br>device comply with<br>IEC60601-2-10 for<br>performance<br>requirement | | | Number of Output Modes | 2 | 2 | 2 | 9 (one less output) | Similar:<br>Two output modes of<br>subject device are<br>basically like two<br>outputs of predicate | | | | | | | | | | | | | | | | device (Russian and<br>Interferential). The<br>minor difference does<br>not raise different<br>question of safety and<br>effectiveness | | | Synchronous or alternating? | Alternating | Alternating | N/A (1 channel only) | Synchronous | Different:<br>The subject device will<br>not raise any safety<br>concerns of output<br>current by alternating<br>stimulation mode, and<br>the subject device<br>complies with<br>IEC60601-2-10 for this<br>performance<br>requirement. The<br>difference does not<br>raise different<br>questions of safety<br>and effectiveness | | | Method of Channel Isolation | Transformer isolated | Transformer isolated | Transformer isolated | Not Available | - | | | Regulated Current or Regulated<br>Voltage? | Regulated Voltage (CV) | Regulated Voltage<br>(CV) | Regulated Voltage (CV) | Not Available | The subject device<br>complies with<br>IEC60601-2-10 for<br>performance<br>requirement. So, such<br>a minor difference<br>does not raise<br>different question of<br>safety and<br>effectiveness. | | | Software/Firmware/Microprocesso<br>r Control? | yes | yes | yes | yes | Same | | | Automatic Over current Trip?<br>Yes/no | yes | yes | yes | yes | Same | | | Automatic Overload Trip? Yes/no | yes | yes | yes | yes | Same | | | Automatic No-Load Trip? Yes/no | yes | yes | yes | yes | Same | | | Automatic Shut Off? Yes/no | | yes | yes | yes | yes | Same | | Patient Override Control? Yes/no | | yes | yes | yes | yes | Same | | Patient Override Control method | | Removal of patient<br>connector at the<br>device. | Removal of patient<br>connector at the<br>device. | Removal of patient<br>connector at the<br>device. | Patient interrupt<br>switch | Different:<br>The subject device<br>does not have a<br>patient interrupt<br>switch like the<br>predicate device. The<br>subject device has an<br>automatic shutdown<br>function and an<br>overload protection<br>function that can<br>monitor the<br>unintended change in<br>the intensity of<br>current that can<br>prevent the patient<br>from unexpected<br>conditions. the<br>difference would not<br>affect the safety and<br>effectiveness of the<br>subject device. | | Indicator<br>Display | On/Off Status?<br>Yes/ No | Yes | Yes | Yes | Same | | | | Low Battery<br>Yes/No | No | No | No | Different:<br>The subject device<br>does not use battery<br>for its operation. This<br>eliminates the risks<br>associated with that<br>function. Therefore,<br>the subject device will<br>not have any safety or<br>effectiveness concerns | | | | Voltage/Current<br>Level? | Yes | Yes | Yes | associated with this<br>function | | | Timer Range | | 1 – 90 min | 1 – 90 min | 1 – 90 min | 0-60 min | Similar:<br>The timer range in the<br>subject device is<br>within the range or<br>slightly above the<br>range of the predicate<br>device. The design of<br>the timer range is<br>based on the intended<br>use. the operating<br>time is adjustable by<br>the operator<br>according to<br>physician's direction.<br>So, the difference in<br>timer setting range<br>would not impact its<br>safety and<br>effectiveness<br>compared to the<br>predicate devices | | Compliance with 21 CFR 898? | | Yes | Yes | Yes | yes | Same | | Compliance with voluntary<br>standards<br>• IEC60601-1<br>• IEC60601-1-2<br>• IEC60601-2-10<br>• ISO14971<br>• IEC62304<br>• IEC62366 | | Yes | Yes | Yes | Information not<br>available | Same | | Weight (lbs., oz,) | | 24.2508 lbs. without<br>accessories | 24.2508 lbs. without<br>accessories | 5.5 lbs. without<br>accessories | 4.5 lb. | Different<br>There are minor<br>differences between | | | | | | | | | | Dimensions (in.) [W x H x D] | 13.77" x 11.41" x 13.77" | 13.77" x 11.41" x<br>13.77" | 10.6" x 9.64" x 2.36" | 8" x 8" x13" | the subject device and<br>the predicate devices<br>in device weight. But<br>the subject device<br>complies with<br>IEC60601-1, and<br>IEC60601-2-10<br>Standard<br>requirement. Different<br>design criteria will<br>have no effect on its<br>function and does not<br>raise safety and<br>performance concerns<br>Different<br>There are minor<br>differences between<br>the subject device and<br>the predicate devices<br>in device weight. But<br>the subject device<br>complies with<br>IEC60601-1, and<br>IEC60601-2-10<br>Standard<br>requirement. Different<br>dimensions will have<br>no effect on its<br>function and does not<br>raise safety and<br>performance concerns | | | Environment of use…