Who is the manufacturer of Compex Sport Elite 3.0?

Djo, LLC filed the 510(k) submission for Compex Sport Elite 3.0 (K201653).

What is the FDA product code for Compex Sport Elite 3.0?

NGX. It is classified under 21 CFR 890.5850 as a Class 2 device in the Physical Medicine panel.

What is the regulatory pathway for Compex Sport Elite 3.0?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Compex Sport Elite 3.0?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Compex Sport Elite 3.0

K201653 · Djo, LLC · NGX · Nov 27, 2020 · Physical Medicine

Device Facts

Record ID	K201653
Device Name	Compex Sport Elite 3.0
Applicant	Djo, LLC
Product Code	NGX · Physical Medicine
Decision Date	Nov 27, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 890.5850
Device Class	Class 2
Attributes	Therapeutic

Intended 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 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 Story

Compex Sport Elite 3.0 is a 4-channel microprocessor-controlled electrical stimulator; delivers electrical impulses via electrodes to motor nerves (NMES) for muscle contraction/conditioning or sensory nerves (TENS) for pain relief. Device used by adults in home/OTC setting. User interacts via graphic LCD, keypad, and menu-driven UI to select programs (Endurance, Resistance, Strength, etc.), adjust intensity, and view electrode placement guides. System includes stimulator, lead wires, snap electrodes, charging cable, and carrying case. Device transforms user-selected parameters into regulated current pulses; features automatic overload/no-load trip and patient override. Benefits include muscle performance improvement and pain management. Output is electrical stimulation; healthcare providers/users monitor progress via display.

Clinical Evidence

Bench testing only. No clinical data presented. Safety and performance verified via testing to ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, IEC 60601-2-10, IEC 62133-2, and ANSI/AAMI/IEC 62304.

Technological Characteristics

4-channel electrical stimulator; microprocessor-controlled. Materials: ABS plastic casing, PMMA windows, silicone sleeve. Energy: 3.7V Li-ion battery, USB-rechargeable. Output: Symmetrical biphasic waveform, regulated current. Connectivity: USB port for factory/service updates. Software: Dual MCU design (STM32F103VCT Master, MSP430F1101 Protection). IP22 ingress protection. Sterilization: N/A (electrodes are cleared components).

Indications for Use

Indicated for adults for EMS to stimulate healthy muscles to improve/facilitate muscle performance (not for rehabilitation/physiotherapy) and TENS for temporary relief of pain from exercise/household/work strain, and symptomatic relief/management of chronic, intractable pain and arthritis-associated pain.

Regulatory Classification

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.

Predicate Devices

Compex Sport Elite (K170918)

Related Devices

K170918 — Compex Sport Elite · Djo, LLC · Jun 20, 2017
K170903 — Compex Wireless USA · Djo, LLC · Jun 19, 2017
K243131 — Triathlon Pro · Sigma Biomedical · Nov 7, 2025
K251856 — Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4 · Everyway Medical Instruments Co.,Ltd · Nov 21, 2025
K211736 — Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W) · Shenzhen Osto Technology Company Limited · Sep 5, 2021

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K201653 Device Name Compex® Sport Elite 3.0 Indications for Use (Describe) 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. | 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) #### 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}------------------------------------------------ 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, LLC 1430 Decision Street Vista, CA 92081 FDA Establishment Registration: 2020737 | |------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Michael Davis Regulatory 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 - 21 CFR 890.5850; Product Code NGX; Review Panel: Physical Medicine (primary product code) | | | Stimulator, Nerve, Transcutaneous, Over-The-Counter- 21 CFR 882.5890; Product Code NUH; Review Panel: Neurology | | | Stimulator, Electrical, Transcutaneous, For Arthritis 21 CFR 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) | {4}------------------------------------------------ ## 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). 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. {5}------------------------------------------------ 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. {6}------------------------------------------------ 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 | Electrodes connection | Lead wires including female custom SNAP plugged on the custom Compex female SNAP assembled in the electrode. Entire electronic circuit for four (4) Stimulation Channels and User Interface is combined into same casing, connected to the electrodes with 6-pole cables. | Lead wires including female custom SNAP plugged on the custom Compex female SNAP assembled in the electrode. Entire electronic circuit for four (4) Stimulation Channels and User Interface is combined into same casing, connected to the electrodes with 6-pole cables. | 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 | | 3 | Battery Charger Regulation | Discrete components with MCU regulate the battery charging | Independent charging IC to regulate battery charging with protection monitor. | Different | Subject device utilizes an independent charging IC to perform protection work during charging or discharging process, this reduces MCU involvement in regulation and simplifies the design. No additional risk | | No | Characteristic | Predicate Device | Subject Device | Same/ Similar/ Different | Risk Analysis (HAZ-PRO-130) | | 4 | Transformer | 1. Input voltage: 4.8V 2. Size: EFD15 3. N1: 2.7uH, N2: 350uH 5. Output power: 10W | 1. Input voltage: 3.7V 2. Size: EFD15 (same) 3. N1: 2.6uH, N2:650uH 5. Output power: 10W(same) | Similar | Same mechanical structure and output. Lower input voltage (3.7V) of subject device leads to the input current and inductance value increase to achieve the same output power. No additional risk. | | 5 | Number of Output 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 deviceprovides the Micro-USB charging port which allows to connect to USB power adapter or PC (user convenience) 2. USB charging is more reliable method which reduces hazard ID1.2.15 'battery overcharging'. 3. No additional risk. | | 7 | Number of Output Channels | Four | Four | Same | No additional risk. | | 8 | LCD | 1. LCD type: MonoSTN LCD, 128 * 64pixel 2. Data Bus: 8-Bits Bus by MCU system bus 3. Backlight: 2 serial 3 parallel (total 6 LEDs) | 1. LCD type: ColorTFTLCD, 320 * 240 pixel 2. Data Bus: 16-Bits Busby special LCD 8080port 3. Backlight: 4 Parallel LEDs | Different | 1. The backlight are LEDs 2. The drive and control method all are PWM technology 3. The method for max current limiting for LEDare all same by hardware 4. TFT display has better performance on resolution and viewing angle than | | No | Characteristic | Predicate Device | Subject Device | Same/ Similar/ Different | Risk Analysis (HAZ-PRO-130) | | 9 | LED Indicator | No LEDs for User Interface | 1. LED: Five indicating LEDs, four are for channel buttons and the other one is for central confirmation button. 2. LED Drive & Power: 5V Power supply with lightadjusting | Different | 1. Common LED 2. The drive circuit limits the max current of LED lower than 20mA in hardware. Software PWM adjusts the LED brightness. No additional risk | | 10 | Synchronous Or Alternating | Synchronous, but never 2 channels activated at the same time | Synchronous, but never 2 channels activated at the same time | Same | No additional risk | | 11 | Method of Channel Isolation | Each channel is the middle of an H-Bridge. Except when it is activated, each channel is always in high impedance state. | Each channel is the middle of an H-Bridge. Except when it is activated, each channel is always in high impedance state. | Same | No additional risk | | 12 | Regulated Current or Regulated Voltage | Regulated current (all channels) | Regulated current (all channels) | Same | No additional risk | | 13 | Software Microprocessor Control | Yes | Yes | Same | No additional risk | | No | Characteristic | Predicate Device | Subject Device | Same/ Similar/ Different | Risk Analysis (HAZ-PRO-130) | | 14 | Automatic Overload Trip | Yes | Yes | Same | No additional risk | | 15 | Automatic No- Load Trip | Yes | Yes | Same | No additional risk | | 16 | Automatic Shut Off | "On/Off" switch | "On/Off" switch | Same | No additional risk | | 17 | Patient Override Control | Yes, push on On/Off button directly pauses the program | Yes, push on On/Off button directly pauses the program | Same | No additional risk | | 18 | Indicator Display - On/Off Status | Yes | Yes | Same | No additional risk | | 19 | Indicator Display - Low Battery Detection | Yes | Yes | Same | No additional risk | | 20 | Indicator Display Voltage /Current Level | Yes, unit = [Energy] The Max/Min level showed on display is 999/0 | Yes, unit = [Energy] The Max/Min level showed on display 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 | Housing Materials and Construction | Casing: Plastic (ABS, with PMMA on the windows) Buttons: Silicon rubber ABS housing around the battery cells Battery contacts: SK5 steel | Casing: Plastic (ABS, with PMMA on the windows) Buttons: Plastic ABS Silicone sleeve: Silicone + Gas phase glue | Similar | 1. Silicone sleeve is designed to meet IP22. 2. uses biocompatible materials used on other devices 3. No additional risk | | 23 | Dimensions | 142*99*36mm | Without silicone sleeve: 136mm*76mm*21mm With silicone sleeve: 140mm*80mm*24.6mm | 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 pin female connector | Different | 1. The subject device provide customized charging port which reduces the occurrence of hazard ID 1.1.11 'incorrect connection terminals' 2. No additional risk | | 26 | BOSS feature | Yes | Yes | Same | No additional risk | | 27 | Part number of MCU | Renesas: M30620SPGP, up to 24Mhz, RAM 10K (External ROM 512K) VCC= 3V and 5V, LQFP100 | ST: STM32F103VCT, 32bit up to 72Mhz, RAM 48K ROM 256K, VCC= 3V, LQFP100 | Different | The performance of ARM MCU of subject device is improved. No additional risk. | | 28 | Data library | Shared with MCU ROM | External 64M bit SPI Flash memory | Different | The subject device stores a much larger data library in external flash memory. No additional risk | | 29 | РСВ | PCB layers: 4 layers Size: 75mm * 120mm * T:1.6mm Surface treatment: gold plating Flammability rating: UL 94V0 | PCB layers: 4 layers Size: 72mm * 125mm *T:1.6mm Surface treatment: gold plating Flammability rating: UL 94 V0 | Similar | The only difference is the PCB size. No additional risk. | | 30 | Library Update Port | UART | USB | Different | The communication port is different, but the function is same. All with CRC verification. 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 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 | | 34 | Maximum Output Current (±10%) | 120 mA @ 500 Ω 82 mA @ 2 kΩ 16 mA @ 10 kΩ | 120 mA @ 500 Ω 82 mA @ 2 kΩ 16 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] (measured at 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] @ 500Ω Excitation pulse fully compensated | 0 [µC] @ 500Ω Excitation pulse fully compensated | Same | No additional risk | | 38 | Maximum Phase Charge [µC] | 48 [µC] @ 500Ω | 48 [µC] @ 500Ω | Same | No additional risk | | No | Characteristic | Predicate Device | Subject Device | Same/ Similar/ Different | Risk analysis | | 39 | Maximum Current Density [mA/cm2] | 1.49 [mA/cm2] @ 500Ω | 1.49 [mA/cm2] @ 500Ω | Same | No additional risk | | 40 | Maximum Power Density [mW/cm2] | 27.6 [mW/cm2] @ 500Ω | 27.6 [mW/cm2] @ 500Ω | Same | No additional risk | {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ {11}------------------------------------------------ ### Table 2 Output Specifications Comparison Analysis {12}------------------------------------------------ ### Table 3 Software Comparison Analysis | No | Characteristic | Predicate Device | Subject Device | Same/ Similar/ Different | Risk Analysis | |----|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 41 | Dual MCU design Master MCU is used to control treatment program and user interface. Protection MCU is used to monitor the operation of the Master MCU and the treatment output. | Master MCU: M30620SPGP, up to 24Mhz, RAM 10K (External ROM 512K) VCC= 3V and 5V, LQFP100 Protection MCU: MSP430F1101 | Master MCU: STM32F103VCT, 32bit, up to 72Mhz, RAM 48K ROM 256K, VCC= 3V, LQFP100 Protection MCU: MSP430F1101 | 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. | | No | Characteristic | Predicate Device | Subject Device | Same/ Similar/ Different | Risk Analysis | | 42 | Development Environment | Boot: Renesas IDE Main firmware: Renesas IDE Protection system: IAR | Boot: IAR Main firmware: Keil Protection system: IAR | Similar | 1. The functionalityof boot and main firmware for both devices are the same. 2. No additional risk | | 43 | Software /Firmware Organization | Software is divided into Boot, Main Firmware. | Software is divided into Boot, Main Firmware, Libraries, Manufacturing and Branding Records, Live Records | Different | Subject device uses a more updated software organization tool. Reduced risk | | 44 | Keyboard- Buttons design | Power ON button Information button 4 channel selection buttons. 4 up/down buttons for treatment strength adjustment | Power On button Five button guide wheel for information, user set up, and program strength adjustment. 4 channel selection buttons | Similar | Subject device offers easier user interaction. No additional risk. | | 45 | UI Screens - Favorites screen | Does not exist | Allows user to set up favorites screen | Different | Subject device offers user a quicker device start. No additional risk. | | 46 | UI Screens - Program screen | Allows user to select various user settings for the device, such as language, sound volume, display contrast, etc. | Allows user to select various user settings for the device, such as time, date, language, power saving mode, etc. | Similar | Subject device offers a better user experience. No additional risk. | | No | Characteristic | Predicate Device | Subject Device | Same/ Similar/ Different | Risk Analysis | | 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. | | 48 | UI Screens - Level selection screen | 5 treatment levels are selected by the up-down button and viewable on the display | 5 treatment levels are selected by the guiding wheel and the viewable on the display | Same | No additional risk | | 49 | UI Screens - Channels selection screen | Insert the treatment lead wire to the corresponding output port, then press the channel button to add corresponding channels. | Insert the treatment lead wire to the corresponding output port, then press the channel button to add corresponding channels. | Same | No additional risk | | 50 | UI Screens - Stimulation screen | Text and graphic information | Text and graphic information | Similar | Subject device offers better treatment progress information to user. No additional risk | | 51 | UI Screens - Stim pause screen and Stim completed screen | Text and graphic information | Text and graphic information | Similar | Subject device offers better treatment progress information to user. No additional risk | | 52 | UI Screens -<br…

Compex Sport Elite 3.0

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Compex Sport Elite 3.0

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