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 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.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA for the HiTop® series of powered muscle stimulators. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving performance against acceptance criteria for a novel AI/software function.

Therefore, most of the requested information (related to AI model performance, test sets, ground truth establishment, expert adjudication, MRMC studies, and standalone performance) is not applicable to this document as it does not describe an AI medical device or a clinical performance study using a test set against predefined acceptance criteria for such a device. This submission is for a traditional powered muscle stimulator.

However, I can extract the information that is relevant from the provided text:

1. A table of acceptance criteria and the reported device performance:

This document describes a comparison to a predicate device (Sys*Stim 240, K113017) to demonstrate substantial equivalence, not performance against specific acceptance criteria for a new AI algorithm. The "acceptance criteria" here are implicitly that the new device is as safe and effective as the predicate, and that any differences do not raise new questions of safety and effectiveness.

The document provides a detailed comparison table of technical characteristics and output specifications. Below is an excerpt of key comparisons, presented as a "performance" summary in the context of demonstrating substantial equivalence. The "Acceptance Criteria" column would effectively be "Similar to Predicate" or "Does not raise new safety/effectiveness concerns."

Characteristic	HiToP® (Subject Devices) Performance	Predicate Device (Sys*Stim 240) Performance	SE Comparison (Outcome vs. Implicit Acceptance Criteria)
Indications for Use	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.	Powered muscle stimulator: Relaxation of muscle spasms, Prevention or retardation of disuse atrophy, Increase local blood circulation, Muscle re-education, Maintaining or increasing range of motion. TENS: Symptomatic relief and management of chronic, intractable pain, Post-traumatic acute pain, Post-surgical acute pain. Also includes DC Mode, laser, and cluster applicators.	Similar: The indications are identical, with the predicate having additional indications and functionalities (DC mode, laser) that are not applicable to the subject device, thus not introducing new risks for the subject device.
Product Code	IPF, LIH, GZJ	IPF, ILY, GZJ, LIH	Similar: Subject device does not include Product Code ILY (Infrared Lamp), which eliminates risks associated with that function.
Regulation Number	21 CFR 890.5850	21 CFR 890.5850, 21 CFR 890.5500	Similar: 21 CFR 890.5500 (Infrared Lamp) is not applicable to the subject device, eliminating associated risks.
Patient Leakage Current (Normal Condition)	HiToP®4touch: 4.7 µA, HiToP®2touch: 4.7 µA, HiToP®1touch: 8.0 µA	78 µA (Less than 100 µA)	Similar: Subject device demonstrated electrical safety by passing ANSI AAMI ES60601-1 and IEC 60601-2-10 tests. Difference does not raise safety/effectiveness concerns.
Patient Leakage Current (Single Fault Condition)	HiToP®4touch: 34 µA, HiToP®2touch: 34 µA, HiToP®1touch: 16.0 µA (all AC SFC 264V 60 Hz)	78 µA (Less than 500 µA)	Similar: Subject device demonstrated electrical safety by passing ANSI AAMI ES60601-1 and IEC 60601-2-10 tests. Difference does not raise safety/effectiveness concerns.
Number of Output Modes	2	9 (one less output, implying 10 total)	Similar: Two output modes are like two outputs of predicate (Russian and Interferential). Minor difference does not raise different safety/effectiveness questions.
Synchronous or Alternating?	Alternating (N/A for 1 channel model)	Synchronous	Different but acceptable: Alternating mode does not raise safety concerns and complies with IEC60601-2-10. Does not raise different questions of safety and effectiveness.
Power Source	100-240V~, 50-60 Hz, AC Line only	AC line or optional battery pack 10.8 V Lithium Ion	Different but acceptable: Subject device is AC line only, no battery pack, which does not introduce new risks and complies with IEC 60601-1. _
Patient Override Control Method	Removal of patient connector at the device.	Patient interrupt switch	Different but acceptable: Subject device has automatic shutdown and overload protection functions to prevent unexpected conditions. The difference does not affect safety and effectiveness.
Low Battery Indicator?	No	Yes	Different but acceptable: Subject device does not use battery, eliminating associated risks. No safety or effectiveness concerns.
Timer Range	1 – 90 min (HiToP®4touch, HiToP®2touch), 1.5 – 120 s (HiToP®1touch)	0-60 min	Similar: Timer range is within or slightly above predicate. Adjustable based on physician's direction; differences in setting range do not impact safety and effectiveness.
Housing Material	Aluminum	ABS Plastic	Different but acceptable: Complies with IEC60601-1 and IEC60601-2-10. Different materials have no effect on function and do not raise safety/performance concerns.
Waveform	Biphasic (medium frequency sine wave)	Medium Frequency (Russian), Biphasic, High Volt Pulsed Current (HVPC), Interferential (4P) and Pre-modulated (2P3)	Same: Subject device has medium frequency sine waveform same as Russian and interferential output in predicate device.
Maximum Output Current	100mA@500 Ω load, 38mA@2 k Ω, 7.6mA@10 k Ω	Not Available (but implied to be comparable given SE determination)	Complies with Standards: Output current complies with IEC60601-2-10. Difference would not affect safety and effectiveness.
Maximum Output Voltage	76V per channel @ all tested loads	Not Available (but implied to be comparable given SE determination)	Complies with Standards: Output voltage complies with IEC60601-2-10. Difference would not affect safety and effectiveness.

2. Sample sized used for the test set and the data provenance:

Not applicable. This submission relies on "non-clinical performance" (bench testing and adherence to standards) and comparison to a predicate device, rather than a clinical performance study with a test set of patient data.
Benchtop Performance Testing: This included testing of output waveforms, basic unit characteristics, output specifications, and uniform current distribution. The "sample size" here refers to test procedures performed on the device itself, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No test set of patient data requiring expert ground truth or review was used for this submission. The "ground truth" for demonstrating substantial equivalence is the safety and effectiveness profile of the predicate device, demonstrated through adherence to recognized standards and comparison of technical characteristics.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No test set of patient data requiring adjudication was used.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a physical muscle stimulator and TENS unit, not an AI-powered diagnostic or assistive device that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an algorithm-only device. Its function is to deliver electrical impulses directly.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable. The "ground truth" in this context is established by the well-understood principles of electrical muscle stimulation and TENS, and the regulatory history and safety profile of the predicate device. Compliance with recognized electrical safety and EMC standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10) serves as the basis for proving performance and safety.

8. The sample size for the training set:

Not applicable. This device does not use an AI algorithm that requires a training set.

9. How the ground truth for the training set was established:

Not applicable. No training set was used.

Summary of relevant data provided in the document:

Sterilization & Shelf-life Testing: Not Applicable (Device is non-sterile).
Biocompatibility Testing: Performed with ISO 10993-1, evaluating Cytotoxicity (ISO 10993-5), Skin Irritation (ISO 10993-10), and Sensitization (ISO 10993-10) for conductive rubber electrodes. (Note: Nylatex® wraps not evaluated for biocompatibility).
Electrical safety and electromagnetic compatibility (EMC):
- Electrical Safety Testing: IEC 60601-1
- EMC Testing: IEC 60601-1-2
- Home Use Environment: IEC 60601-1-11
- Nerve and Muscle Stimulators: IEC 60601-2-10
Software Verification and Validation Testing: Performed in accordance with IEC 62304 and FDA guidance documents.
Benchtop Performance Testing: Conducted for Output waveforms, Basic unit characteristics, Output specifications, and Uniform current distribution.
Animal Study: Not required.
Human Clinical Performance Testing: Not required.

The core of this 510(k) submission is the demonstration, through bench testing and comparison to an existing legally marketed device, that the HiToP® devices are "as safe, as effective, and performs as well as the legally marketed predicate devices and any differences between the devices do not pose any new questions of safety and effectiveness."

Summary

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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

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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

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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)

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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

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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 ModelHiToP®4 touch	Subject device ModelHiToP®2 touch	Subject device ModelHiToP®1 touch	Primary PredicateDeviceSys*Stim 240	SE comparison
--------	---------------------------------------	---------------------------------------	---------------------------------------	---------------------------------------------	---------------

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Submitter	HillTek LLC	HillTek LLC	HillTek LLC	Mettler ElectronicsCorp	-		Interferential CurrentTherapy LIH	Interferential CurrentTherapy LIH	Interferential CurrentTherapy LIH	Interferential CurrentTherapy LIH	Same
510K Number	K213655	K213655	K213655	K113017	-		NA	NA	NA	Lamp, Infrared,Therapeutic HeatingILY	Different:The subject device isnot a Lamp, Infrared,Therapeutic Heatingdevice. Therefore,product code ILY is notapplicable to thesubject device. Thiseliminates the risksassociated with thatfunction
Common or Usual Name	TranscutaneousElectrical NerveStimulator for painreliefPowered MuscleStimulator	TranscutaneousElectrical NerveStimulator for painreliefPowered MuscleStimulator	TranscutaneousElectrical NerveStimulator for painreliefPowered MuscleStimulator	TranscutaneousElectrical NerveStimulator for painreliefPowered MuscleStimulator	Same	Regulation Number	21 CFR 890.5850	21 CFR 890.5850	21 CFR 890.5850	21 CFR 890.585021 CFR 890.5500	Similar21 CFR 890.5500 isused for Lamp,Infrared, TherapeuticHeating device that isnot applicable to thesubject device. Thiseliminates the risksassociated with thatfunction
	NA	NA	NA	Infrared lamp	-	Indications for Use	Powered musclestimulator• Relaxation ofmuscle spasms• Increase localblood circulation• Muscle re-education• Maintaining orincreasing range ofmotionTENS	Powered musclestimulator• Relaxation ofmuscle spasms• Increase localblood circulation• Muscle re-education• Maintaining orincreasing rangeof motionTENS	Powered musclestimulator• Relaxation ofmuscle spasms• Increase localblood circulation• Muscle re-education• Maintaining orincreasing range ofmotion	Indications forMedium Frequency(Russian), Biphasic,High Volt PulsedCurrent (HVPC),Interferential (4P) andPremodulated (2P3)waveforms:Relaxation of musclespasms• Prevention orretardation ofdisuse atrophy	Similar:The indication of useis identical in bothsubject device andpredicate devices. Theadditional indicationsfor use i.e Indicationsfor DC (Direct Current)Mode and the laserand cluster applicatorsin the predicatedevices is notapplicable for the
Product Code	IPF, LIH, GZJ	IPF, LIH, GZJ	IPF, LIH, GZJ	IPF, ILY, GZJ, LIH	SimilarThe subject device isused for electricalstimulation. It is not aLamp, Infrared,Therapeutic Heatingdevice. Therefore,product code ILY is notapplicable to thesubject device. Thiseliminates the risksassociated with thatfunction
Product Classification	Class II	Class II	Class II	Class II	Same
Classification Name	Stimulator, nerve,transcutaneous, forpain relief (GZJ)Stimulator, muscle,powered (IPF)	Stimulator, nerve,transcutaneous, forpain relief (GZJ)Stimulator, muscle,powered (IPF)	Stimulator, nerve,transcutaneous, forpain relief (GZJ)Stimulator, muscle,powered (IPF)	Stimulator, nerve,transcutaneous, forpain relief (GZJ)Stimulator, muscle,powered (IPF)	Same

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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
----------------------------------------------------------------	----------------------------------------------------------------	----------------------------------------------------------------------	-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	------------------------------------------------------------------------------------------------------------------

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Type of Use	Prescription (Rx Only)	Prescription (Rx Only)	Prescription (Rx Only)	Prescription (Rx Only)	SameDifferent:
Power Source(s)	100-240V~, 50-60 Hz,200VA / AC Line	100-240V~, 50-60 Hz,120VA / AC Line	100-240V~, 50-60 Hz,45VA / AC Line	AC line or optionalbattery pack 10.8 V ACline or optionalbattery pack LithiumIon	The subject device islimited to use with ACline as the powersource. The subjectdevice does notinclude an optionalbattery pack like thepredicate device, andthis does notintroduce any newrisks. The subjectdevice complies withIEC 60601-1requirements forevaluation of safety.These differences do
Sys*Stim 240 emit infrared energy for: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 andeffectiveness
Method of Line Current Isolation	2 MOPP	2 MOPP	2 MOPP	Yes, value unknown	Similar:The subject device hasbeen tested forelectrical isolationprotection againstelectric shockaccording to standardrequirement IECIEC60601-1. Does notraise any safety andeffectiveness concerns
Patient leakage current - normalcondition (μΑ)	4.7 μΑ	4.7 μΑ	8.0 μΑ	78 μΑ (Less than 100 μΑ)	Similar:The subject devicedemonstratedelectrical safety bypassing ANSI AAMIES60601-1 and IEC60601-2-10 tests. Thedifference does notraise the issue ofproduct's safety andeffectiveness.
Patient leakage current - singlefault condition (μΑ)	34μΑ(AC SFC 264V 60 Hz)	34μΑ(AC SFC 264V 60 Hz)	16.0μΑ(AC SFC 264V 60 Hz)	78 µA (Less than 500 μΑ)
Number of Output Channels	4	2	1	2	The number ofchannels of outputcurrent do not affectthe treatment, andthe design of subjectdevice comply withIEC60601-2-10 forperformancerequirement
Number of Output Modes	2	2	2	9 (one less output)	Similar:Two output modes ofsubject device arebasically like twooutputs of predicate

					device (Russian andInterferential). Theminor difference doesnot raise differentquestion of safety andeffectiveness
Synchronous or alternating?	Alternating	Alternating	N/A (1 channel only)	Synchronous	Different:The subject device willnot raise any safetyconcerns of outputcurrent by alternatingstimulation mode, andthe subject devicecomplies withIEC60601-2-10 for thisperformancerequirement. Thedifference does notraise differentquestions of safetyand effectiveness
Method of Channel Isolation	Transformer isolated	Transformer isolated	Transformer isolated	Not Available	-
Regulated Current or RegulatedVoltage?	Regulated Voltage (CV)	Regulated Voltage(CV)	Regulated Voltage (CV)	Not Available	The subject devicecomplies withIEC60601-2-10 forperformancerequirement. So, sucha minor differencedoes not raisedifferent question ofsafety andeffectiveness.
Software/Firmware/Microprocessor Control?	yes	yes	yes	yes	Same
Automatic Over current Trip?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 patientconnector at thedevice.	Removal of patientconnector at thedevice.	Removal of patientconnector at thedevice.	Patient interruptswitch	Different:The subject devicedoes not have apatient interruptswitch like thepredicate device. Thesubject device has anautomatic shutdownfunction and anoverload protectionfunction that canmonitor theunintended change inthe intensity ofcurrent that canprevent the patientfrom unexpectedconditions. thedifference would notaffect the safety andeffectiveness of thesubject device.
IndicatorDisplay	On/Off Status?Yes/ No	Yes	Yes	Yes	Same
	Low BatteryYes/No	No	No	No	Different:The subject devicedoes not use batteryfor its operation. Thiseliminates the risksassociated with thatfunction. Therefore,the subject device willnot have any safety oreffectiveness concerns
	Voltage/CurrentLevel?	Yes	Yes	Yes	associated with thisfunction
Timer Range		1 – 90 min	1 – 90 min	1 – 90 min	0-60 min	Similar:The timer range in thesubject device iswithin the range orslightly above therange of the predicatedevice. The design ofthe timer range isbased on the intendeduse. the operatingtime is adjustable bythe operatoraccording tophysician's direction.So, the difference intimer setting rangewould not impact itssafety andeffectivenesscompared to thepredicate devices
Compliance with 21 CFR 898?		Yes	Yes	Yes	yes	Same
Compliance with voluntarystandards• IEC60601-1• IEC60601-1-2• IEC60601-2-10• ISO14971• IEC62304• IEC62366		Yes	Yes	Yes	Information notavailable	Same
Weight (lbs., oz,)		24.2508 lbs. withoutaccessories	24.2508 lbs. withoutaccessories	5.5 lbs. withoutaccessories	4.5 lb.	DifferentThere are minordifferences between

Dimensions (in.) [W x H x D]	13.77" x 11.41" x 13.77"	13.77" x 11.41" x13.77"	10.6" x 9.64" x 2.36"	8" x 8" x13"	the subject device andthe predicate devicesin device weight. Butthe subject devicecomplies withIEC60601-1, andIEC60601-2-10Standardrequirement. Differentdesign criteria willhave no effect on itsfunction and does notraise safety andperformance concernsDifferentThere are minordifferences betweenthe subject device andthe predicate devicesin device weight. Butthe subject devicecomplies withIEC60601-1, andIEC60601-2-10Standardrequirement. Differentdimensions will haveno effect on itsfunction and does notraise safety andperformance concerns
Environment of use	Healthcare facilities andHospitals	Healthcare facilitiesand Hospitals	Healthcare facilitiesand Hospitals	Information notavailable	Same
Electrode shape (square, round,rectangular, oval) in cm²	Rectangular12, 48, 96,200	Rectangular12, 48, 96,200	Rectangular12, 48, 96,200.	Not Available	-
Housing Material and Construction	Aluminum	Aluminum	Aluminum	ABS Plastic	DifferentThere are minordifferences between
					the subject device andthe predicate devicesin device weight. Butthe subject devicecomplies withIEC60601-1, andIEC60601-2-10Standardrequirement. Differentmaterials will have noeffect on its functionand does not raisesafety andperformance concern

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OUTPUT SPECIFICATIONS -Comparison of Subject Device Models with Predicate Rx Device

	Subject device ModelHiToP4 touch	Subject device ModelHiToP2 touch	Subject device ModelHiToP1 touch	Predicate DeviceSys*Stim 240	SE Comparison
Waveform (e.g., pulsedmonophasic, biphasic)	Biphasic	Biphasic	Biphasic	MediumFrequency(Russian), Biphasic,High Volt PulsedCurrent (HVPC),Interferential (4P)and Pre-modulated(2P3)	Same:Subjectdevice hasmediumfrequencysinewaveformsame asRussian andinterferentialoutput inpredicatedevice.
Maximum output Current (±20%)	100mA@500 Ω load38mA@2 k Ω7.6mA@10 k Ω	100mA@500 Ω load38mA@2 k Ω7.6mA@10 k Ω	100mA@500 Ω load38mA@2 k Ω7.6mA@10 k Ω	Not Available	The outputcurrent of thesubjectdevice

Maximum output voltage (±20%)	76V per channel@500 Ω 76V perchannel @2k Ω76V per channel@10k Ω	76V per channel @500Ω 76V per channel @2kΩ76V per channel @10kΩ	76V per channel @500Ω 76V per channel @2kΩ76V per channel @10kΩ	Not Available	complies withstandardrequirementof IEC60601-2-10.Therefore,thedifferencewould notaffect safetyandeffectivenessof the subjectdevice.Note: As thedeviceoperates involtage-controlledmode, it isnormal thatwith higherresistancesthe currentgoes down.the outputvoltage of thesubjectdevicecomplies withstandardrequirementof IEC60601-2-10.Therefore,thedifferencewould not
					affect safetyandeffectivenessof the subjectdevice.
Frequency	4096 – 32768 Hz	4096 – 32768 Hz	4096 – 32768 Hz	Not Available	The device
Pulse Width	1 s – 120 s	1 s – 120 s	1.5 s – 120 s	Not Available	complies with
Maximum Current Density,(mA/cm²)	100mA @ 500 Ω/12cm² = 8.3	100mA @ 500 Ω /12cm²= 8.3	100mA @ 500 Ω/12cm² = 8.3	Not Available	IEC60601-1,andIEC60601-
Maximum Power Density,(W/CM²), (using smallestelectrode conductive surfacearea)	5W / 12cm²=0.42	5W / 12cm²=0.42	5W / 12cm²=0.42	Not Available	2- 10 forsafetyevaluation

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The following performance data were provided in support of the substantial equivalence determination.

Sterilization & Shelf-life Testing

Not Applicable- Device is non-sterile.

Biocompatibility Testing

Biocompatibility assessment of conductive rubber electrodes in the subject device was performance with iso 10993-1, "biological evaluation of medical devices - part 1: evaluation and testing within a risk management process" as recognized by FDA. The following endpoints were evaluated for conductive rubber electrodes.

· Cytotoxicity ISO 10993-5
Skin Irritation ISO 10993-10
· Sensitization ISO 10993-10

NOTE:

Nylatex® wraps have not been evaluated for biocompatibility. Precautionary statements and the measures necessary to mitigate the risks in the event of an adverse event associated with the use of the Nylatex® wraps are included within the device labeling.

Electrical safety and electromagnetic compatibility (EMC)

The following electrical safety and EMC testing reports were provided:

Electrical Safety Testing IEC 60601-1 .
EMC Testing IEC 60601-1-2 .

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Home Use Environment IEC 60601-1-11 ●
Nerve and Muscle Stimulators IEC 60601-2-10

Software Verification and Validation Testing

Software verification and validation testing was provided in accordance with IEC 62304 and FDA guidance documents.

Benchtop Performance Testing

The following benchtop performance testing was provided:

. Output waveforms
Basic unit characteristics .
Output specifications .
. Uniform current distribution

Animal Study

Animal performance testing was not required to demonstrate safety and effectiveness of the device.

Human Clinical Performance Testing

Clinical testing was not required to demonstrate the safety and effectiveness of the device.

VII. CONCLUSIONS

Based on the comparison to the predicate device and on the outcome of non-clinical performance that the subject device is as safe, as effective, and performs as well as the legally marketed predicate devices and any differences between the devices do not pose any new questions of safety and effectiveness. Thus, the HiToP® models are substantially equivalent to the predicate device.

Regulation Number and Section

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).