EMS: The Compex Sport Elite 3.0 is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The work imposed on the Compex Sport Elite 3.0 programs is not suitable for relabilitation or physiotherapy.

TENS: The Compex Sport Elite TENS is intended for:

Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities:
The symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

The Compex Sport Elite 3.0 is an Over-the-Counter device to be used by adults only.

Device Description

The Compex Sport Elite 3.0 is an electrical stimulation device, which stimulates healthy muscles by means of electrical impulses transmitted by electrodes. The electrical pulses generated by the Compex Sport Elite 3.0 stimulates motor nerves to stimulate a muscular response. Depending on the parameters of theelectrical impulses (pulse frequency. duration of contraction, duration of rest, and totalsession duration). different types of muscle work can be imposed on the stimulated muscles. The Compex Sport Elite 3.0 may therefore be considered a technique of muscletraining.

TENS (Transcutaneous Electrical Nerve Stimulation) and NMES (NeuroMuscular Electrical Stimulation) target different nerve groups of the body. TENS specifically targets the sensory nerves, which are responsible for sending pain signals to the brain. NMES targets the muscle itself, specifically through the motor nerves. This allows the NMES machine to create a muscle contraction to recruit more muscle fibers when training; warming up or recovering.

The Compex Sport Elite 3.0 system consists of these components:

1x Stimulator
1x Lead WireSet
2x Small Performance Snap Electrodepackages ●
2x Large Performance Snap Electrodepackages
1x Charging Cable ●
1x Carrying Case ●

These components are packaged together in a carrying case along with the user guide and a battery charger.

The electrodes are supplied by Axelgaard Mfg. Co., Inc. and cleared under K130987.

The stimulator is a microprocessor controlled 4-channel electro-stimulator. The stimulator drives each output channel independently based upon the parameters predefined for a program selected by the user operates the device through a User Interface (UI) consisting of a graphic LCD, keypad controls and supporting software. The User Interface is made up of different menus that allow the following functions: set up the device (Options Menu), select a desired category (Category Menu), select a preset program (Treatments ) Menu), tune a selected program (Stimulation Menu), andadiust the stimulation intensities (Level Menu).

AI/ML Overview

The provided document is a 510(k) summary for a medical device, the Compex® Sport Elite 3.0. This type of submission to the FDA focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving de novo safety and effectiveness through extensive clinical trials. Thus, the information requested in your prompt regarding acceptance criteria, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set details for AI/ML-based devices is not applicable to this specific document.

The document primarily addresses acceptance criteria in the context of non-clinical testing and comparison to the predicate device. The study proving the device meets these "acceptance criteria" is a demonstration of substantial equivalence rather than a clinical performance study.

Here's an analysis of the provided information within the context of a 510(k) submission, addressing the questions where applicable:

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

The document doesn't present "acceptance criteria" in the traditional sense of a performance study with specific numerical thresholds for accuracy, sensitivity, or specificity for an AI/ML device. Instead, the acceptance criteria are implicitly defined by the safety and performance standards the device was tested against and by its substantial equivalence to the predicate device.

The document provides a "Comparison Analysis" (Table 1: Characteristics, Table 2: Output Specifications, Table 3: Software Comparison Analysis) between the subject device (Compex® Sport Elite 3.0) and its predicate device (Compex Sport Elite, K170918). This comparison itself serves as the "reported device performance" against the "acceptance criteria" of being substantially equivalent to the predicate and meeting relevant safety standards.

Table 1: Comparison Analysis - Characteristics (Excerpt)

No	Characteristic	Predicate Device	Subject Device	Same/Similar/Different	Risk Analysis (HAZ-PRO-130)
1	Electrodes connection	[Description]	[Description]	Same	No additional risk.
2	Power Source	Rechargeable Ni-MH battery 4.8V (4 cells AA=R6); replaceable.	Rechargeable Li-ion battery 3.7V (one cell); not replaceable.	Different	Smaller size; reduced weight. User will not handle battery. The battery conforms to IEC 62133-2 and UN DOT 38.3. No additional risk.
...	...	...	...	...	...
24	Ingress Protection	IP20	IP22	Different	IP22 is required by IEC 60601-1-11. Reduced risk.
...	...	...	...	...	...

Table 2: Output Specifications Comparison Analysis (Excerpt)

No	Characteristic	Predicate Device	Subject Device	Same/Similar/Different	Risk analysis
33	Maximum Output Voltage (±10%)	60 V @ 500 Ω, 165 V @ 2 kΩ, 165 V @ 10 kΩ	60 V @ 500 Ω, 165 V @ 2 kΩ, 165 V @ 10 kΩ	Same	No additional risk
35	Pulse Width	NMES: 200 to 400 [µs], TENS: 70 to 300[µs]	NMES: 200 to 400 [µs], TENS: 70 to 300[µs]	Same	No additional risk
...	...	...	...	...	...

Table 3: Software Comparison Analysis (Excerpt)

No	Characteristic	Predicate Device	Subject Device	Same/Similar/Different	Risk Analysis
41	Dual MCU design	[Description]	[Description]	Different master MCU, Same protection MCU	Subject device's master MCU has improved performance for control and user interface. Same protection MCU is used. No additional risk.
47	UI Screens - Placements selection screen	Does not exist, need reference to printed user guide	Using graphic display to inform user the proper location of the treatment electrode pads on a human body diagram.	Different	Subject device offers clearer usage guide. Reduced risk.
...	...	...	...	...	...

The "acceptance criteria" here are that the subject device performs identically or similarly to the predicate device in terms of critical functional and safety parameters, and any differences do not raise new issues of safety or effectiveness. For "Different" or "Similar" characteristics, the risk analysis justifies why these differences do not introduce new risks or even reduce existing ones (e.g., improved ingress protection).

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

Sample Size: Not applicable. This is a medical device (muscle stimulator), not an AI/ML diagnostic or prognostic system that processes clinical data. The "testing" refers to bench testing and comparison to a predicate, not performance on a clinical test set of patient data.
Data Provenance: Not applicable for clinical data. The provenance for the testing data would be from laboratory bench tests conducted by a Nationally Recognized Test Laboratory (Nemko Shanghai Ltd. Shenzhen Branch).

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

Not applicable. Ground truth as in expert consensus on disease status is not relevant for this type of device and submission. The "ground truth" for the device's technical specifications and safety conformity would be the industry standards (e.g., IEC 60601 series) and the specifications of the predicate device.

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

Not applicable. Adjudication methods are used in clinical studies, particularly for subjective assessments or when establishing ground truth from multiple readers. This is a technical comparison and safety conformity assessment.

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 an electrical stimulator, not an AI-assisted diagnostic tool.

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 direct physical electrical stimulation.

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

The "ground truth" for this 510(k) submission is based on:

International safety and performance standards: e.g., ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, IEC 60601-2-10, IEC 62133-2, ANSI/AAMI/IEC 62304.
Specifications and performance of the legally marketed predicate device (Compex Sport Elite, K170918): The core of the 510(k) submission is to demonstrate that the new device is "substantially equivalent" to this predicate.

8. The sample size for the training set:

Not applicable. There is no AI/ML component with a training set for this device.

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

Not applicable. There is no AI/ML component with a training set for this device.

In summary: The provided document is an FDA 510(k) clearance letter and summary for a physical medical device (muscle stimulator). The "study that proves the device meets the acceptance criteria" refers to bench testing against recognized electrical safety and performance standards and a detailed comparison to a legally marketed predicate device to demonstrate substantial equivalence, rather than a clinical trial or performance study typical for AI/ML-driven diagnostic devices.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & 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.

November 27, 2020

DJO, LLC Michael Davis Regulatory Affairs Consultant 1430 Decision Street Vista. California 92081

Re: K201653

Trade/Device Name: Compex® Sport Elite 3.0 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX, NUH, NYN Dated: June 16, 2020 Received: June 18, 2020

Dear Michael Davis:

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 Actinclude 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

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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-devices/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 (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 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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201653

Device Name Compex® Sport Elite 3.0

Indications for Use (Describe)

TENS: The Compex Sport Elite TENS is intended for:

Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities:
The symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

The Compex Sport Elite 3.0 is an Over-the-Counter device to be used by adults only.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for DJO, a company that specializes in powering motion. The logo features a red circle with a white curved line inside, followed by the letters "DJO" in black. Below the logo, the text "DJO, LLC / 1430 Decision Street / Vista, CA 92081 / 800.321.9549 / djoglobal.com" is displayed in gray.

510(k) Summary

This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.

The assigned 510(k)number is

Submitted by:	DJO, LLC1430 Decision StreetVista, CA 92081FDA Establishment Registration: 2020737
Contact Person:	Michael DavisRegulatory Affairs Site Lead(205) 789-8154
Date Summary Prepared:	November 24, 2020
Trade Name:	Compex® Sport Elite3.0
Common Name:	Stimulator, Muscle
Classification Name:	Stimulator, muscle, powered (21 CFR890.5850)Stimulator, Nerve, Transcutaneous (21 CFR 882.5890)
Product Code:	Powered Muscle Stimulator, For Muscle Conditioning - 21CFR 890.5850; Product Code NGX; Review Panel:Physical Medicine (primary product code)
	Stimulator, Nerve, Transcutaneous, Over-The-Counter- 21CFR 882.5890; Product Code NUH; Review Panel:Neurology
	Stimulator, Electrical, Transcutaneous, For Arthritis 21CFR 890.5850; Product Code NYN (subsequent code);Review Panel: Neurology
Regulatory Class:	Class II
Predicate Device:	Compex Sport Elite (K170918) - ClassII(Manufacturer's own predicate device)

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Device Description:

The Compex Sport Elite 3.0 system consists of these components:

1x Stimulator
1x Lead WireSet
2x Small Performance Snap Electrodepackages ●
2x Large Performance Snap Electrodepackages
1x Charging Cable ●
1x Carrying Case ●

These components are packaged together in a carrying case along with the user guide and a battery charger.

The electrodes are supplied by Axelgaard Mfg. Co., Inc. and cleared under K130987.

See Appendix 5 Illustrated Device Description for a detailed description.

Indications for Use:

EMS: The Compex Sport Elite 3.0 is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The work imposed on the muscles by the Compex Sport Elite 3.0 programs is not suitable for rehabilitation or physiotherapy.

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TENS: The Compex Sport Elite 3.0 TENS is intended for:

Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal householdandworkactivities;
The symptomatic relief and management of chronic, intractable pain and relief of pain associated witharthritis.

The Compex Sport Elite 3.0 is an Over-the-Counter device to be used by adults only.

Summary of Non-clinical Tests:

The subject device has been evaluated for safety and performance by lab bench testing in accordance with the following standards:

1. ANSI/AAMI ES60601-1:2005/(R) 2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD)
ANSI/AAMI/IEC 60601-1-2:2014. Medical Electrical Equipment -- Part 1-2: 2. General Requirements For Basic Safety And Essential Performance -- Collateral Standard: Electromagnetic Disturbances -- Requirements And Tests
IEC 60601-1-6 Edition 3.1 2013-10, Medical Electrical Equipment Part 1-6: 3. General Requirements For Basic Safety And Essential Performance - Collateral Standard: Usability
IEC 60601-1-11 Edition2.0 2015-01, Medical electrical equipment Part 1-11: 4. General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
IEC 60601-2-10 Edition 2.1 2016-04, Medical Electrical Equipment Part 2-10: 5. Particular Requirements For The Basic Safety And Essential Performance Of Nerve And MuscleStimulators
IEC 62133-2 Edition 1.0 2017-02, Secondary Cells And Batteries Containing 6. Alkaline Or Other Non-Acid Electrolytes - Safety Requirements For Portable Sealed Secondary Cells, And For Batteries Made From Them, For Use In Portable Applications - Part 2: LithiumSystems
ANSI/AAMI/IEC 62304:2006/A1:2016. Medical Device Software Software 7. LifeCycle Processes [Including Amendment 1 (2016)]

Comparison to the Predicate Device and Conclusion:

The changes do not affect the intended use and do not alter the fundamental scientific technology of the predicate device: Compex Sport Elite (K170918). The subject device Compex Sport Elite 3.0 technological characteristics, features, specifications, materials, mode of operation and intended use are substantially equivalent to the predicate device named above. The differences between the subject device and predicate device do not raise new issues of safety or effectiveness.

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The subject device has undergone testing by a Nationally Recognized Test Laboratory, Nemko Shanghai Ltd. Shenzhen Branch, to assure safety and conformance to standards for Electromagnetic Compatibility. Further, the subject device conforms to existing design controls procedures per §820.30. Below is a comparison analysis between the subject and predicatedevices: Table 1 Comparison Analysis

No	Characteristic	Predicate Device	Subject Device	Same/Similar/Different	Risk Analysis(HAZ-PRO-130)
1	Electrodesconnection	Lead wires including femalecustom SNAP plugged on thecustom Compex female SNAPassembled in the electrode.Entire electronic circuit for four(4) Stimulation Channels andUser Interface is combined intosame casing, connected to theelectrodes with 6-pole cables.	Lead wires including femalecustom SNAP plugged on thecustom Compex female SNAPassembled in the electrode.Entire electronic circuit for four(4) Stimulation Channels andUser Interface is combined intosame casing, connected to theelectrodes with 6-pole cables.	Same	No additional risk.
2	Power Source	Rechargeable Ni-MHbattery 4.8V (4 cellsAA=R6);replaceable.	Rechargeable Li-ion.battery 3.7V (one cell); notreplaceable.	Different	Smaller size; reduced weight.User will not handle battery.The battery conforms to IEC62133-2 and UN DOT 38.3.No additional risk
3	Battery ChargerRegulation	Discrete components withMCU regulate the batterycharging	Independent charging IC toregulate battery charging withprotection monitor.	Different	Subject device utilizes anindependent charging IC toperform protection workduring charging ordischarging process, thisreduces MCU involvement inregulation and simplifies thedesign.No additional risk
No	Characteristic	Predicate Device	Subject Device	Same/Similar/Different	Risk Analysis(HAZ-PRO-130)
4	Transformer	1. Input voltage: 4.8V2. Size: EFD153. N1: 2.7uH, N2: 350uH5. Output power: 10W	1. Input voltage: 3.7V2. Size: EFD15 (same)3. N1: 2.6uH, N2:650uH5. Output power: 10W(same)	Similar	Same mechanical structureand output.Lower input voltage (3.7V) ofsubject device leads to theinput current and inductancevalue increase to achieve thesame output power.No additional risk.
5	Number ofOutput Modes	Two (NMES/TENS)	Two (NMES/TENS)	Same	No additional risk.
6	Power Adapter	DC jack male charging port,9V/400mA power adapter	Micro-USB male charging port,5V/2A USB power adapter or PC	Different	1. Thesubject deviceprovidesthe Micro-USB charging portwhich allows to connect toUSB power adapter or PC(user convenience)2. USB charging is morereliable method whichreduces hazard ID1.2.15'battery overcharging'.3. No additional risk.
7	Number ofOutputChannels	Four	Four	Same	No additional risk.
8	LCD	1. LCD type: MonoSTNLCD, 128 * 64pixel2. Data Bus: 8-Bits Busby MCU system bus3. Backlight: 2 serial 3parallel (total 6 LEDs)	1. LCD type: ColorTFTLCD,320 * 240 pixel2. Data Bus: 16-Bits Busbyspecial LCD 8080port3. Backlight: 4 Parallel LEDs	Different	1. The backlight are LEDs2. The drive and controlmethod all are PWMtechnology3. The method for maxcurrent limiting for LEDareall same by hardware4. TFT display has betterperformance on resolutionand viewing angle than
No	Characteristic	Predicate Device	Subject Device	Same/Similar/Different	Risk Analysis(HAZ-PRO-130)
9	LED Indicator	No LEDs for UserInterface	1. LED: Five indicating LEDs,four are for channel buttonsand the other one is for centralconfirmation button.2. LED Drive & Power: 5V Powersupply with lightadjusting	Different	1. Common LED2. The drive circuit limits themax current of LED lowerthan 20mA in hardware.Software PWM adjusts theLED brightness. No additionalrisk
10	SynchronousOr Alternating	Synchronous, but never 2channels activated at the sametime	Synchronous, but never 2channels activated at the sametime	Same	No additional risk
11	Method ofChannelIsolation	Each channel is the middle ofan H-Bridge. Except when it isactivated, each channel isalways in high impedancestate.	Each channel is the middle ofan H-Bridge. Except when it isactivated, each channel isalways in high impedancestate.	Same	No additional risk
12	RegulatedCurrent orRegulatedVoltage	Regulated current (all channels)	Regulated current (all channels)	Same	No additional risk
13	SoftwareMicroprocessorControl	Yes	Yes	Same	No additional risk
No	Characteristic	Predicate Device	Subject Device	Same/Similar/Different	Risk Analysis(HAZ-PRO-130)
14	AutomaticOverload Trip	Yes	Yes	Same	No additional risk
15	Automatic No-Load Trip	Yes	Yes	Same	No additional risk
16	Automatic ShutOff	"On/Off" switch	"On/Off" switch	Same	No additional risk
17	Patient OverrideControl	Yes, push on On/Off buttondirectly pauses the program	Yes, push on On/Off buttondirectly pauses the program	Same	No additional risk
18	Indicator Display- On/Off Status	Yes	Yes	Same	No additional risk
19	Indicator Display- Low BatteryDetection	Yes	Yes	Same	No additional risk
20	Indicator DisplayVoltage/Current Level	Yes, unit = [Energy]The Max/Min level showed ondisplay is 999/0	Yes, unit = [Energy]The Max/Min level showed ondisplay is 999/0	Same	No additional risk
21	Timer Range(minutes)	Yes, unit= [seconds],max = 55 [minutes]	Yes, unit= [seconds],max = 55 [minutes]	Same	No additional risk
22	HousingMaterials andConstruction	Casing: Plastic(ABS, with PMMA on thewindows)Buttons: Silicon rubberABS housing around thebattery cells Battery contacts:SK5 steel	Casing: Plastic(ABS, withPMMA on thewindows)Buttons: Plastic ABSSilicone sleeve: Silicone + Gasphase glue	Similar	1. Silicone sleeve is designedto meet IP22.2. uses biocompatiblematerials used on otherdevices3. No additional risk
23	Dimensions	1429936mm	Without silicone sleeve:136mm76mm21mmWith silicone sleeve:140mm80mm24.6mm	Different	Subject device is more compact.No additional risk
No	Characteristic	Predicate Device	Subject Device	Same/Similar/Different	Risk Analysis (HAZ-PRO-130)
24	Ingress Protection	IP20	IP22	Different	IP22 is required by IEC 60601-1-11. Reduced risk.
25	Type of Charging Port	DC Jack female charging port	USB type-A customized 5 pinfemale connector	Different	1. The subject device providecustomized charging portwhich reduces theoccurrence of hazard ID1.1.11 'incorrect connectionterminals'2. No additional risk
26	BOSS feature	Yes	Yes	Same	No additional risk
27	Part number of MCU	Renesas: M30620SPGP, up to24Mhz, RAM 10K (ExternalROM 512K) VCC= 3V and 5V,LQFP100	ST: STM32F103VCT, 32bit up to72Mhz, RAM 48K ROM 256K,VCC= 3V, LQFP100	Different	The performance of ARMMCU of subject device isimproved. No additional risk.
28	Data library	Shared with MCU ROM	External 64M bit SPI Flashmemory	Different	The subject device stores amuch larger data library inexternal flash memory. Noadditional risk
29	РСВ	PCB layers: 4 layersSize: 75mm * 120mm * T:1.6mmSurface treatment: gold platingFlammability rating: UL 94V0	PCB layers: 4 layersSize: 72mm * 125mm *T:1.6mmSurface treatment: gold platingFlammability rating: UL 94 V0	Similar	The only difference is thePCB size. No additional risk.
30	Library Update Port	UART	USB	Different	The communication port isdifferent, but the function issame. All with CRCverification. No additional risk.
No	Characteristic	Predicate Device	Subject Device	Same/Similar/Different	Risk analysis
31	Waveform	Symmetrical Biphasic	Symmetrical Biphasic	Same	No additional risk
32	Shape	Rectangular	Rectangular	Same	No additional risk
33	Maximum OutputVoltage (±10%)	60 V @ 500 Ω165 V @ 2 kΩ165 V @ 10 kΩ	60 V @ 500 Ω165 V @ 2 kΩ165 V @ 10 kΩ	Same	No additional risk
34	Maximum OutputCurrent (±10%)	120 mA @ 500 Ω82 mA @ 2 kΩ16 mA @ 10 kΩ	120 mA @ 500 Ω82 mA @ 2 kΩ16 mA @ 10 kΩ	Same	No additional risk
35	Pulse Width	NMES:200 to 400 [µs] (microseconds)TENS:70 to 300[µs] (measured at 50%of positive pulse)	NMES:200 to 400 [µs](microseconds)TENS:70 to 300[µs] (measuredat 50% of positive pulse)	Same	No additional risk
36	Frequency	1 to 120 Hz	1 to 120 Hz	Same	No additional risk
37	Net Charge[µC/pulse]	0 [µC] @ 500ΩExcitation pulse fullycompensated	0 [µC] @ 500ΩExcitation pulse fullycompensated	Same	No additional risk
38	Maximum PhaseCharge [µC]	48 [µC] @ 500Ω	48 [µC] @ 500Ω	Same	No additional risk
No	Characteristic	Predicate Device	Subject Device	Same/Similar/Different	Risk analysis
39	MaximumCurrent Density[mA/cm2]	1.49 [mA/cm2] @ 500Ω	1.49 [mA/cm2] @ 500Ω	Same	No additional risk
40	Maximum PowerDensity[mW/cm2]	27.6 [mW/cm2] @ 500Ω	27.6 [mW/cm2] @ 500Ω	Same	No additional risk

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Table 2 Output Specifications Comparison Analysis

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Table 3 Software Comparison Analysis

No	Characteristic	Predicate Device	Subject Device	Same/Similar/Different	Risk Analysis
41	Dual MCU designMaster MCU isused to controltreatmentprogram and userinterface.Protection MCUis used to monitorthe operation ofthe Master MCUand the treatmentoutput.	Master MCU: M30620SPGP, up to24Mhz, RAM 10K (External ROM512K) VCC= 3V and 5V, LQFP100Protection MCU:MSP430F1101	Master MCU: STM32F103VCT,32bit, up to 72Mhz, RAM 48KROM 256K, VCC= 3V, LQFP100Protection MCU: MSP430F1101	Differentmaster MCUSameprotectionMCU	Subject device'smaster MCU hasimprovedperformance forcontrol and userinterface. Sameprotection MCU isused.No additional risk.
No	Characteristic	Predicate Device	Subject Device	Same/Similar/Different	Risk Analysis
42	DevelopmentEnvironment	Boot: Renesas IDEMain firmware: Renesas IDEProtection system: IAR	Boot: IARMain firmware: KeilProtection system: IAR	Similar	1. The functionalityofboot and mainfirmware for bothdevices are thesame.2. No additional risk
43	Software/FirmwareOrganization	Software is divided into Boot,Main Firmware.	Software is divided into Boot,Main Firmware, Libraries,Manufacturing and BrandingRecords, Live Records	Different	Subject device usesa more updatedsoftware organizationtool. Reduced risk
44	Keyboard-Buttons design	Power ON buttonInformation button4 channel selection buttons.4 up/down buttons fortreatment strength adjustment	Power On buttonFive button guide wheel forinformation, user set up, andprogram strength adjustment.4 channel selection buttons	Similar	Subject device offerseasier userinteraction. Noadditional risk.
45	UI Screens -Favorites screen	Does not exist	Allows user to set up favoritesscreen	Different	Subject device offersuser a quicker devicestart. No additionalrisk.
46	UI Screens -Program screen	Allows user to select varioususer settings for the device,such as language, soundvolume, display contrast, etc.	Allows user to select various usersettings for the device, such astime, date, language, powersaving mode, etc.	Similar	Subject device offersa better userexperience. Noadditional risk.
No	Characteristic	Predicate Device	Subject Device	Same/Similar/Different	Risk Analysis
47	UI Screens -Placementsselection screen	Does not exist, need referenceto printed user guide	Using graphic display to informuser the proper location of thetreatment electrode pads on ahuman body diagram.	Different	Subject device offersclearer usage guide.Reduced risk.
48	UI Screens -Level selectionscreen	5 treatment levels are selectedby the up-down button andviewable on the display	5 treatment levels are selected bythe guiding wheel and theviewable on the display	Same	No additional risk
49	UI Screens -Channelsselection screen	Insert the treatment lead wire tothe corresponding output port,then press the channel button toadd corresponding channels.	Insert the treatment lead wire tothe corresponding output port,then press the channel button toadd corresponding channels.	Same	No additional risk
50	UI Screens -Stimulationscreen	Text and graphic information	Text and graphic information	Similar	Subject device offersbetter treatmentprogress informationto user. No additionalrisk
51	UI Screens - Stimpause screenand Stimcompleted screen	Text and graphic information	Text and graphic information	Similar	Subject device offersbetter treatmentprogress informationto user. No additionalrisk
52	UI Screens -Setting screen	Offers sound, language, displaycontrast selection	Offers sound, language, powersaving setting selection. Chineseis added.	Similar	Subject device offersbetter userexperience. Noadditional risk
53	UI Screens -Charging screen	Uses an icon on the display toshow the device batterycharging progress.	Uses an icon on the display toshow the device battery chargingprogress.	Same	No additional risk
No	Characteristic	Predicate Device	Subject Device	Same/Similar/Different	Risk Analysis
54	UI Screens -Electrode faultscreen	Graphic and text information"display electrode faultsymbol on screen, a twinklingarrow points to the faultchannel"	Graphic and text information"display electrode fault symbol onscreen, a twinkling arrow pointsto the fault channel, LED of faultchannel flashes"	Similar	1. Subject deviceoffers better userexperience.2. No additional risk
55	UI Screens -Lowbattery screen	Graphic and test informationThere is a battery icon toindicate the charge state (6bars mean the battery is fullycharged), if the battery iconcontains just two bars, thismeans the power is runninglow, need to recharge the unit	Graphic and test informationThere is a battery icon to indicatethe charge state (4 bars mean thebattery is fully charged).4 bars indicate full battery (4.0-4.2V)3 bars indicate almost full (3.8-4.0V)2 bars indicate half-empty (3.6-3.8V)1 white bar indicates almost empty(3.5-3.6V)1 red bar indicates empty(<3.5V)	Similar	1. Subject deviceoffers better userexperience.2. No additional risk
56	Firmware &Library Update	Firmware and library can beupdated from UART port inthe factory or service center	Firmware and library can beupdated from customized USBport in the factory or servicecenter. Unit charging or upgradesuse same USB port, which isconvenient in production andupgrades is not available for user	Different	1.Subject deviceprovides the USBdata transmitconnector which iskeyed and can onlybe connected in oneorientation andreduces theoccurrence HazardID 1.1.11 'incorrectconnection terminals'2.User cannotupdatethe firmware andlibrary via USB portwithout permission
No	Characteristic	Predicate Device	Subject Device	Same/Similar/Different	Risk Analysis
					from manufacture,there is no impact onits safety andeffectiveness. Noadditional risk
57	External FlashLibrary DataStructure	Does not exist	Uses external flash to storelibraries to graphics, treatmentprogram and multi languageinterface.	Different	Subject device offersbetter userexperience.No additional risk
58	CRC verificationfor master MCUcode	CRC algorithm is used forsoftware integrity control.	CRC algorithm is used forsoftware integrity control.	Same	No additional risk
59	CommunicationProtocol	UART communicationprotocol that is developed forthe production software anddevice control	USB communication protocol thatis developed for the productionsoftware and device control	Different	1. Bothcommunicationprotocols are used forproduction purposeand do not impactsafety andeffectiveness on endusers2. Subject deviceuses USBcommunicationprotocol which isconvenient to servicepersonnel (reduceshazard ID 7.4.1 'bador inadequatemaintenance')3. No additional risk
No	Characteristic	Predicate Device	Subject Device	Same/Similar/Different	Risk Analysis
60	Programs	Muscle Building1-Endurance2-Resistance3-Strength4-Explosive strengthWarm Up & Recovery5-Prewarm Up6-Training recovery7-Competition recovery8-Muscle relaxation9-PotentiationPain Management10-Pain Relief TENS	Muscle Building1-Endurance2-Resistance3-Strength4-Explosive strengthWarm Up & Recovery5-Prewarm Up6-Training recovery7-Competition recovery8-Muscle relaxation9-PotentiationPain Management10-Pain Relief TENS	Same	No additional risk
61	MSP430 ProtectSystemDevelopmentEnvironment	IAR	IAR	Same	No additional risk
62	ProtectionSystem ReportError	12 error codes	13 error codes.The first 12 error codes are thesame as predicate device.The No. 13th error code is toensure both ST32 (main MCU)and MSP430 (protection systemMCU) are working normally at thesame time.	Similar	1. The new 13therrorcode is to checkMCU workingproperly2. No additional risk
63	CRC Verificationof ProtectionSystem Code	CRC algorithm is used for softwareintegrity control.	CRC algorithm is used forsoftware integrity control.	Same	No additional risk

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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).