(162 days)
Not Found
No
The document describes a microprocessor-controlled electrical stimulator with predefined programs selected by the user. There is no mention of AI, ML, or any adaptive or learning capabilities.
Yes.
The device is intended for "Temporary relief of pain associated with sore and aching muscles" and "The symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis," which are therapeutic indications.
No
The Compex Sport Elite 3.0 is intended to stimulate healthy muscles to improve performance or provide temporary pain relief, and its use is not suitable for rehabilitation or physiotherapy. It focuses on muscle stimulation (NMES) and pain relief (TENS) rather than diagnosing medical conditions.
No
The device description explicitly lists hardware components such as a stimulator, lead wire set, electrodes, charging cable, and carrying case. It is an electrical stimulation device that transmits electrical impulses via electrodes.
Based on the provided text, the Compex Sport Elite 3.0 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Compex Sport Elite 3.0 Function: The description clearly states that the Compex Sport Elite 3.0 is an electrical stimulation device that applies electrical impulses to the body through electrodes to stimulate muscles or nerves. It works externally on the body, not by analyzing samples taken from the body.
- Intended Use: The intended use is for stimulating healthy muscles to improve performance (EMS) and for temporary pain relief (TENS). These are direct applications to the body, not diagnostic tests performed on samples.
Therefore, the Compex Sport Elite 3.0 falls under the category of an electrical stimulator for therapeutic and performance enhancement purposes, not an In Vitro Diagnostic device.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
NGX, NUH, NYN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adults only
Intended User / Care Setting
Over-The-Counter device
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The subject device has been evaluated for safety and performance by lab bench testing in accordance with the following standards:
-
- 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)]
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Compex Sport Elite (K170918)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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:
-
- 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.
- uses biocompatible
materials used on other
devices - No additional risk |
| 23 | Dimensions | 1429936mm | Without silicone sleeve:
136mm76mm21mm
With 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 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' - 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 -
Setting screen | Offers sound, language, display
contrast selection | Offers sound, language, power
saving setting selection. Chinese
is added. | Similar | Subject device offers
better user
experience. No
additional risk |
| 53 | UI Screens -
Charging screen | Uses an icon on the display to
show the device battery
charging progress. | Uses an icon on the display to
show the device battery charging
progress. | Same | No additional risk |
| No | Characteristic | Predicate Device | Subject Device | Same/
Similar/
Different | Risk Analysis |
| 54 | UI Screens -
Electrode fault
screen | Graphic and text information
"display electrode fault
symbol on screen, a twinkling
arrow points to the fault
channel" | Graphic and text information
"display electrode fault symbol on
screen, a twinkling arrow points
to the fault channel, LED of fault
channel flashes" | Similar | 1. Subject device
offers better user
experience.
2. No additional risk |
| 55 | UI Screens -Low
battery screen | Graphic and test information
There is a battery icon to
indicate the charge state (6
bars mean the battery is fully
charged), if the battery icon
contains just two bars, this
means the power is running
low, need to recharge the unit | Graphic and test information
There is a battery icon to indicate
the charge state (4 bars mean the
battery 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(