(83 days)
The Compex Wireless USA is an Over-The-Counter device intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is to be used by adults only.
The Compex Wireless USA is not intended for adjunctive therapy in the treatment of medical diseases and conditions of any kind. None of the Compex Wireless USA stimulation programs are designed for injured or disease afflicted muscles. Its use on such muscles is contraindicated. The work imposed on the muscles by the Compex Wireless USA programs is definitely not suitable for rehabilitation and physiotherapy.
The Compex Wireless USA electrical impulses allow the triggering of action potentials on motoneurones of motor nerves (excitations). These excitations of motoneurones are transmitted to the muscle fibers via the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction. duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles. The Compex Wireless USA may therefore be considered a technique of muscle training.
Compex Wireless USA as a TENS device is used 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 Wireless USA employs programs for neuromuscular electrical stimulation (NMES) and transcutaneous electrical stimulation (TENS).
TENS (Transcutaneous Electrical Nerve Stimulation) and NMES (NeuroMuscular Electrical Stimulation) target different nerve groups of the body. TENS is 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 Wireless USA device stimulates nerve fibers by means of electrical impulses transmitted by electrodes. The electrical pulses generated by the Compex Wireless USA stimulate motor nerves to stimulate a muscular response. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, and total session duration), different types of muscle work can be imposed on the stimulated muscles. The Compex Wireless USA may therefore be considered a technique of muscle training.
The device system is made up of a remote control. 4 stimulation modules, and electrodes, which are stored and shipped within the docking station which is used to recharge the remote and the modules. The docking station is powered by an AC-DC adapter.
The remote control is the interface between the stimulation modules and the user. It sends and receives information to and from the modules via a wireless network. The remote control allows the user to navigate through the user interface (UI), select stimulation program or objectives, set desired options and control the four (4) module intensities independently. The remote control is powered by a rechargeable battery.
The Compex Wireless USA stimulation module set is composed of 4 independent stimulation modules that are controlled via the remote control by a wireless connection. Each module is composed of two "pods" (1 battery "pod" and one stimulation "pod") linked by an electrical connection (cable). Two proprietary Compex standard snap gel electrodes are also needed to connect each "pod" to the body. The modules are powered by a Lithium Polymer (LiPo) rechargeable 3.7[V] /> 450 [mAh] battery.
The wireless protocol of the Compex Wireless USA Device is a proprietary design of a Radio-Frequency protocol operating the 2.4 GHz ISM band.
It is used to 1) Send particular information from remote control to stimulation modules (stimulation settings)
-
Send particular information from stimulation modules to remote control. like current stimulation level and stimulation module subsystem status,
-
Transfer binary data to stimulation modules, and
-
Allow synchronization from stimulation modules to remote control clocks.
The provided document is a 510(k) Summary for the Compex Wireless USA, a powered muscle stimulator. It details the device's characteristics, indications for use, and a comparison to predicate devices, along with performance testing conducted. However, it explicitly states, "This submission does not contain clinical data." This means there is no study described in this document that proves the device meets specific acceptance criteria based on clinical outcomes or efficacy in human subjects.
Therefore, the response below will focus on the technical and safety acceptance criteria demonstrated by the performance testing, as clinical efficacy data is not present in the provided text.
Acceptance Criteria and Device Performance for Compex Wireless USA (K170903)
The Compex Wireless USA device, a powered muscle stimulator, demonstrates its compliance with acceptance criteria primarily through non-clinical performance testing related to electrical safety, electromagnetic compatibility, software validation, usability, and wireless coexistence. There is no clinical study information provided in this document to demonstrate the device meets acceptance criteria related to its intended physiological effects (e.g., muscle performance improvement or pain relief).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with AAMI/ANSI 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, Mod.). | "The Compex Wireless USA was tested and found to comply with… standards for electrical safety." (Implies successful adherence to the standard's requirements for basic safety and essential performance). |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 Edition 3:2007-03, Medical Electrical Equipment - Part 1 -2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests. | "The Compex Wireless USA was tested and found to comply with… standards for… electromagnetic compatibility." (Implies successful adherence to the standard's requirements for EMC, ensuring it operates without undue interference and is not unduly affected by other electromagnetic phenomena). |
| FCC Radio Frequency | Compliance with 47 CFR 15.249. | "The Compex Wireless USA was tested to FCC requirements and found to comply with the requirements of 47 CFR 15.249." (Indicates successful compliance with regulations for operating in the 2.4 GHz ISM band.) |
| Software Validation | Verification in accordance with FDA's guidance document: General Principles of Software Validation, January 11, 2002. | "The software testing demonstrated that the software meets its design requirements." (Indicates the software functions as intended and is validated for its specified purpose.) |
| Usability/Human Factors | Established requirements for usability met, and device design appropriate for intended users and use environment. | "Usability/Human Factors testing was performed, which demonstrated that the established requirements for usability were met, and the device's design is appropriate for the intended users and use environment. The result of this study substantiates the acceptability of the use-related risks identified during the risk assessment activities." (Confirms the device is user-friendly and safe in practical use.) |
| Wireless Coexistence | Performance in an environment with other Compex Wireless USA devices and with other types of 2.4 GHz wireless devices (Bluetooth and Wi-Fi) met specific requirements. | "The device met all specified requirements." (Ensures the device can operate effectively without interference in a typical wireless environment.) |
| Risk Management | Compliance with ISO 14971 Second Edition 2007-03-01. Medical Devices - Applications of Risk Management to Medical Devices. | The document states conformance to ISO 14971, implying that risks were identified, analyzed, evaluated, controlled, and monitored in accordance with the standard. |
| Software Life Cycle Processes | Compliance with AAMI /ANSI /IEC 62304:2006, Medical Device Software - Software Life Cycle Processes. | The document states conformance to IEC 62304, indicating that the software development followed recognized life cycle processes for medical device software. |
| Particular Requirements for Nerve and Muscle Stimulators | Compliance with IEC 60601-2-10 Edition 2.0 2012-06, Medical Electrical Equipment - Part 2-10: Particular Requirements for the Basic Safety and Essential Performance of Nerve and Muscle Stimulators. | The document states conformance to IEC 60601-2-10, demonstrating adherence to specific safety and performance standards for its device type. |
| Home Healthcare Environment | Compliance with IEC 60601-1-11 Edition 1.0 2010-04, Medical Electrical Equipment Part 1-11: General Requirements - Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment. | The document states conformance to IEC 60601-1-11, indicating its suitability and safety for use in home healthcare settings. |
2. Sample Size Used for the Test Set and Data Provenance
This document does not provide details on the sample sizes for the test sets used in the performance testing (Electrical Safety, EMC, FCC, Software, Usability, Wireless Coexistence). It also does not specify the country of origin of the data or whether the data was retrospective or prospective. These are typically technical bench tests or simulations rather than human subject studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since the "studies" described are technical performance tests (e.g., electrical safety, EMC, software validation, usability), the concept of "ground truth" established by human experts in a clinical context is not applicable. For these technical tests, compliance is typically determined by accredited testing laboratories and engineers following the specifications of the relevant international and national standards. While these individuals are "experts" in their respective fields (e.g., electrical engineering, software engineering, human factors engineering), they are not referred to in the context of clinical ground truth or adjudication.
4. Adjudication Method for the Test Set
Not applicable, as the "studies" are technical performance tests based on compliance with established standards, not diagnostic or outcome-based clinical evaluations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "This submission does not contain clinical data." Therefore, there is no information on human readers, AI assistance, or effect sizes related to clinical performance. The focus of this submission is on demonstrating substantial equivalence based on technical specifications and non-clinical performance and safety.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
The device is a physical powered muscle stimulator with TENS and NMES capabilities, not an algorithm, AI, or diagnostic software. Therefore, the concept of "standalone (algorithm only)" performance is not applicable in this context. The document describes the technical performance and safety of the device itself and its integrated software.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests described is compliance with established engineering and medical device standards (e.g., IEC 60601 series, ISO 14971, FCC regulations). This is a form of technical or regulatory compliance ground truth, rather than expert consensus, pathology, or outcomes data related to clinical efficacy.
8. The Sample Size for the Training Set
Not applicable. The device is not an AI/ML algorithm that requires a "training set" in the conventional sense. The "training" for such a device involves its design, manufacturing, and calibration processes, guided by engineering principles and standards, not a data-driven machine learning approach.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the reasons stated in point 8.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three human profiles facing right, arranged in a stacked formation. The profiles are connected by flowing lines, creating a sense of unity and movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 12, 2017
DJO, LLC Neeta Sharma Sr. Director, Regulatory Affairs 1430 Decision Street Vista, California 92081
Re: K170903
Trade/Device Name: Compex Wireless USA Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX, NUH, NYN Dated: March 27, 2017 Received: March 28, 2017
Dear Neeta Sharma:
This letter corrects our substantially equivalent letter of June 19, 2017.
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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21
{1}------------------------------------------------
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael J. Hoffmann -S
Carlos L. Peña. PhD. MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K170903
Device Name Compex Wireless USA
Indications for Use (Describe)
The Compex Wireless USA is an Over-The-Counter device intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is to be used by adults only.
The Compex Wireless USA is not intended for adjunctive therapy in the treatment of medical diseases and conditions of any kind. None of the Compex Wireless USA stimulation programs are designed for injured or disease afflicted muscles. Its use on such muscles is contraindicated. The work imposed on the Compex Wireless USA programs is definitely not suitable for rehabilitation and physiotherapy. The Compex Wireless USA electrical impulses allow the triggering of action potentials on motor nerves (excitations). These excitations of motoneurones are transmitted to the muscle fibers via the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles. The Compex Wireless USA may therefore be considered a technique of muscle training.
The Compex Wireless USA TENS is used 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 associated with arthritis.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CER 801 Subpart D) | Over-The-Counter Use (21 CER 801 Subpart C) |
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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 K170903.
| Submitted by: | DJO, LLC1430 Decision StreetVista, CA 92081 |
|---|---|
| Contact Person: | Neeta SharmaSr. Director, Regulatory Affairs760-734-3551 |
| Date Summary Prepared: | March 27, 2017 |
| Trade Name: | Compex® Wireless USA |
| Classification Name: | Powered muscle stimulator (21 CFR 890.5850)Stimulator, Nerve, Transcutaneous (21 CFR 882.5890) |
| Product Code: | Powered Muscle Stimulator, For Muscle Conditioning – 21 CFR 890.5850Product Code NGX; Review Panel: Physical MedicineStimulator, Nerve, Transcutaneous, Over-The-Counter- 21 CFR 882.5890;Product Code NUH; Review Panel: NeurologyStimulator, Electrical, Transcutaneous, For Arthritis 21 CFR 890.5850;Product Code NYN (subsequent code); Review Panel: Neurology |
| Regulatory Class: | Class II |
| Predicate Device: | Compex Wireless USA (K143551)Strive (K153704) |
Device Description:
The Compex Wireless USA employs programs for neuromuscular electrical stimulation (NMES) and transcutaneous electrical stimulation (TENS).
TENS (Transcutaneous Electrical Nerve Stimulation) and NMES (NeuroMuscular Electrical Stimulation) target different nerve groups of the body. TENS is 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.
{4}------------------------------------------------
The Compex Wireless USA device stimulates nerve fibers by means of electrical impulses transmitted by electrodes. The electrical pulses generated by the Compex Wireless USA stimulate motor nerves to stimulate a muscular response. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, and total session duration), different types of muscle work can be imposed on the stimulated muscles. The Compex Wireless USA may therefore be considered a technique of muscle training.
The device system is made up of a remote control. 4 stimulation modules, and electrodes, which are stored and shipped within the docking station which is used to recharge the remote and the modules. The docking station is powered by an AC-DC adapter.
The remote control is the interface between the stimulation modules and the user. It sends and receives information to and from the modules via a wireless network. The remote control allows the user to navigate through the user interface (UI), select stimulation program or objectives, set desired options and control the four (4) module intensities independently. The remote control is powered by a rechargeable battery.
The Compex Wireless USA stimulation module set is composed of 4 independent stimulation modules that are controlled via the remote control by a wireless connection. Each module is composed of two "pods" (1 battery "pod" and one stimulation "pod") linked by an electrical connection (cable). Two proprietary Compex standard snap gel electrodes are also needed to connect each "pod" to the body. The modules are powered by a Lithium Polymer (LiPo) rechargeable 3.7[V] /> 450 [mAh] battery.
The wireless protocol of the Compex Wireless USA Device is a proprietary design of a Radio-Frequency protocol operating the 2.4 GHz ISM band.
It is used to 1) Send particular information from remote control to stimulation modules (stimulation settings)
-
Send particular information from stimulation modules to remote control. like current stimulation level and stimulation module subsystem status,
-
Transfer binary data to stimulation modules, and
-
Allow synchronization from stimulation modules to remote control clocks.
{5}------------------------------------------------
Indications for Use:
The Compex Wireless USA is an Over-The-Counter device intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is to be used by adults only.
The Compex Wireless USA is not intended for adjunctive therapy in the treatment of medical diseases and conditions of any kind. None of the Compex Wireless USA stimulation programs are designed for injured or disease afflicted muscles. Its use on such muscles is contraindicated. The work imposed on the muscles by the Compex Wireless USA programs is definitely not suitable for rehabilitation and physiotherapy.
The Compex Wireless USA electrical impulses allow the triggering of action potentials on motoneurones of motor nerves (excitations). These excitations of motoneurones are transmitted to the muscle fibers via the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction. duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles. The Compex Wireless USA may therefore be considered a technique of muscle training.
Compex Wireless USA as a TENS device is used 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.
Programs:
Muscle Stimulation Training Programs: The Compex Wireless USA provides four muscle stimulation training programs: Endurance, Strength, and Explosive Strength. They correspond to the type of muscle performance the athlete wishes to improve or maintain. Each of the four training programs offers five different working levels that enable the amount of work to be gradually increased.
Specialized Muscle Training Programs: The Compex Wireless USA also offers five special muscle training programs: Potentiation, Training Recovery, Competition Recovery, Muscle Relaxation, and Pre-Warmup. Their objective is to prepare muscles for explosive motions or to facilitate recovery after active muscle training and competition.
TENS Program: Pain Relief TENS program is to alleviate all types of localized pain. Please note that Pain relief TENS was called "Frequency Modulation (FM)" in the predicate device-Strive.
{6}------------------------------------------------
Programs Specification
| Program name | Frequency [Hz] | Contraction duration [s] |
|---|---|---|
| Training recovery | From 1 to 9 Hz continuous | |
| Potentiation | From 1 to 2 Hz continuous | |
| CompetitionRecovery | From 1 to 5 Hz continuous | |
| Pre Warmup | 8 Hz continuous | |
| Endurance | 10 | 9 |
| Explosive strength | 104 | 4.25 |
| Resistance | 50 | 9.25 |
| Strength | 75 | 6.25 |
| Muscle Relaxation | 1Hz continuous | |
| Pain Relief TENS | From 90 to 120 Hz |
Comparison to the Predicate Device:
The similarities and differences between the technology and specifications of the subject device and its predicate devices are reflected below:
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Basic Device Characteristics – Comparison with Predicate Devices Device Comparison Tables
| Basic Unit Characteristics – Comparison with Predicate Device | ||||
|---|---|---|---|---|
| Characteristic | New Device | Predicate Device | Predicate Device | Similar/Different |
| 510(k) Number | Pending | K143551 | K153704 | |
| Device Name, Model | Compex® Wireless USA | Compex® Wireless USA | Strive | |
| Manufacturer | DJO LLC | DJO LLC | DJO LLC | Similar |
| Prescription/OTC | OTC | OTC | OTC | Similar |
| Type of device | A non-implantable, battery powered, hand held, electrical stimulator, used for medical purposes through applying an electrical current to electrodes on a patient's skin | A non-implantable, battery powered, hand held, electrical stimulator, used for medical purposes through applying an electrical current to electrodes on a patient's skin | A non-implantable, battery powered, hand held, electrical stimulator, used for medical purposes through applying an electrical current to electrodes on a patient's skin | Similar |
| Connection of device to electrodes | Lead wiresStimulation Module is directly connected to the custom Compex female SNAP assembled in the electrode. User Interface (LCD and buttons) is physically separated (Remote Control) and communicates wirelessly with up to four (4) Stimulation Modules | Lead wiresStimulation Module is directly connected to the custom Compex female SNAP assembled in the electrode. User Interface (LCD and buttons) is physically separated (Remote Control) and communicates wirelessly with up to four (4) Stimulation | Lead wires | Similar |
| Basic Unit Characteristics – Comparison with Predicate Device | ||||
| Characteristic | New Device | Predicate Device | Predicate Device | Similar/Different |
| Stimulation safety remainsfully managed byStimulation Moduleelectronic circuit itself. | Modules. Stimulationsafety remains fullymanaged by StimulationModule electroniccircuit itself. | |||
| Power Sources | Remote: : LithiumPolymer (LiPo)rechargeable 3.7[V] / ≥1500[mAh]Stimulation Modules:Lithium Polymer (LiPo)rechargeable 3.7[V] / ≥450[mAh] | Remote: : LithiumPolymer (LiPo)rechargeable 3.7[V] / ≥1500[mAh]Stimulation Modules:Lithium Polymer(LiPo) rechargeable3.7[V] / ≥ 450[mAh] | LiPo 250 [mAh] (3.7[V]),not removable | Same as CompexWireless USADifferent fromStrive |
| Method of line currentisolation | N/A (battery operateddevice) | N/A (battery operateddevice) | N/A (battery operateddevice) | Similar |
| Patient Leakage Current | N/A (battery operateddevice) | N/A (batteryoperated device) | N/A (batteryoperated device) | Similar |
| • Normal condition | N/A (battery operateddevice) | N/A (batteryoperated device) | N/A (batteryoperated device) | Similar |
| • Single faultcondition | N/A (battery operateddevice) | N/A (batteryoperated device) | N/A (batteryoperated device) | Similar |
| Number of Output Modes | Two (NMES/TENS) | One (NMES) | Two (2 x TENS) | Different |
| Number of Output Channels | Four | Four | 1, split | Same as CompexWireless USADifferent fromStrive |
| Synchronous or | Synchronous, but | Synchronous, but | N/A | Same as Compex |
| Basic Unit Characteristics – Comparison with Predicate Device | ||||
| Characteristic | New Device | Predicate Device | Predicate Device | Similar/Different |
| Alternating? | never 2 channelsactivated at the sametime | never 2 channelsactivated at thesame time | Wireless USA | |
| - Method of ChannelIsolation | Each channel is themiddle of a H- Bridge.Except when it isactivated, each channel isalways in highimpedance state. | Each channel is themiddle of a H-Bridge. Except whenit is activated, eachchannel is always inhigh impedance state. | N/A | Same as CompexWireless USA |
| Regulated Current orRegulated Voltage? | Regulated current (allchannels) | Regulated current (allchannels) | Regulated Current | Similar |
| Software/Firmware/Microprocessor Control? | Yes | Yes | Yes | Similar |
| Automatic Overload Trip? | Yes | Yes | No | Same as CompexWireless USA |
| Automatic No-Load Trip? | Yes | Yes | Yes | Similar |
| Automatic Shut Off? | "On/Off" switch | "On/Off" switch | "On/Off" switch | Similar |
| Patient Override Control? | Yes, push on On/Off buttondirectly pause the program | Yes, push on On/Off buttondirectly pause the program | Yes, push on On/Off buttondirectly pause the program | Similar |
| Indicator Display- On/Off Status? | Yes | Yes | Yes | Similar |
| - Low Battery? | Yes | Yes | No | Same as CompexWireless USA |
| Basic Unit Characteristics – Comparison with Predicate Device | ||||
| Characteristic | New Device | Predicate Device | Predicate Device | Similar/Different |
| Voltage/Current Level? | Yes, unit = [Energy] | Yes, unit = [Energy] | Active/inactive output | Different from StriveSame as Compex Wireless USA |
| Compliance with 21 CFR 898? | Yes | Yes | Yes | Different from StriveSimilar |
| Weight | Remote: 110 [g]Stimulation Module:2x60 [g]Docking Station 800 [g] | Remote: 110 [g]Stimulation Module:2x60 [g]Docking Station 800 [g] | 0.99 oz | Same as Compex Wireless USADifferent from Strive |
| Waveform (program per program) | -Endurance:Symmetrical Biphasic-Resistance:Symmetrical Biphasic-Strength :Symmetrical Biphasic-Explosive Strength:Symmetrical Biphasic-Potentiation:Symmetrical Biphasic-Training Recovery (same as Active Recovery):Symmetrical Biphasic-Competition | -Endurance:Symmetrical Biphasic-Resistance:Symmetrical Biphasic-Strength : Symmetrical Biphasic-Explosive Strength:Symmetrical Biphasic-Potentiation:Symmetrical Biphasic-Active Recovery:Symmetrical Biphasic-Recovery Plus: | Same as Compex Wireless USADifferent from Strive | |
| Basic Unit Characteristics – Comparison with Predicate Device | ||||
| Characteristic | New Device | Predicate Device | Predicate Device | Similar/Different |
| Recovery (same asRecovery Plus):Symmetrical Biphasic | SymmetricalBiphasic | |||
| -Pre-Warmup Program:Symmetrical Biphasic-Muscle Relaxation (sameas Massage):Symmetrical Biphasic | -Pre-Warmup Program:Symmetrical Biphasic-Massage:Symmetrical Biphasic | |||
| -Pain relief TENS (sameas FM): Balanced,asymetrical Biphasic | Balanced, AsymmetricalBiphasic | Same as StriveDifferent fromCompex SportPlus | ||
| Shape (program perprogram) | -Endurance:Rectangular-Resistance:Rectangular-Strength :Rectangular-Explosive Strength:Rectangular-Potentiation:Rectangular-Training Recovery:Rectangular | -Endurance:Rectangular-Resistance:Rectangular-Strength:Rectangular-Explosive Strength:Rectangular-Potentiation:Rectangular-Training Recovery:Rectangular | Same asCompexWireless USADifferent fromStrive | |
| Basic Unit Characteristics – Comparison with Predicate Device | ||||
| Characteristic | New Device | Predicate Device | Predicate Device | Similar/Different |
| -CompetitionRecovery:Rectangular-Pre-Warmup:Rectangular-Muscle Relaxation:Rectangular | - CompetitionRecovery:Rectangular-Pre-Warmup:Rectangular- Muscle Relaxation:Rectangular | |||
| -Pain relief TENS (sameas FM): | Square positive pulse,current controlledLogarithmic negativepulse,decrease current | Same as StriveDifferent fromCompexWireless USA | ||
| Maximum Output Voltage(± 10%) | Endurance:60 V @ 500 Ω165 V @ 2 kΩ165 V @ 10 kΩ | Endurance:60 V @ 500 Ω165 V @ 2 kΩ165 V @ 10 kΩ | Same asCompexWireless USADifferent fromStrive | |
| Resistance:60 V @ 500 Ω165 V @ 2 kΩ165 V @ 10 kΩ | Resistance:60 V @ 500 Ω165 V @ 2 kΩ165 V @ 10 kΩ | Same asCompexWireless USADifferent fromStrive | ||
| Strength:60 V @ 500 Ω | Strength:60 V @ 500 Ω | Same asCompex | ||
| Basic Unit Characteristics – Comparison with Predicate Device | ||||
| Characteristic | New Device | Predicate Device | Predicate Device | Similar/Different |
| 165 V @ 2 kΩ165 V @ 10 kΩ | 165 V @ 2 kΩ165 V @ 10 kΩ | Wireless USADifferent fromStrive | ||
| Explosive Strength:60 V @ 500 Ω165 V @ 2 kΩ165 V @ 10 kΩ | Explosive Strength:60 V @ 500 Ω165 V @ 2 kΩ165 V @ 10 kΩ | Same asCompexWireless USADifferent fromStrive | ||
| Potentiation:60 V @ 500 Ω152 V @ 2 kΩ136 V @ 10 kΩ | Potentiation:60 V @ 500 Ω152 V @ 2 kΩ136 V @ 10 kΩ | Same asCompexWireless USADifferent fromStrive | ||
| Training Recovery:60 V @ 500 Ω165 V @ 2 kΩ165 V @ 10 kΩ | Training Recovery :60 V @ 500 Ω165 V @ 2 kΩ165 V @ 10 kΩ | Same asCompexWireless USADifferent fromStrive | ||
| Competition Recovery:60 V @ 500 Ω165 V @ 2 kΩ165 V @ 10 kΩ | CompetitionRecovery:60 V @ 500 Ω165 V @ 2 kΩ165 V @ 10 kΩ | Same asCompexWireless USADifferent fromStrive | ||
| Basic Unit Characteristics – Comparison with Predicate Device | ||||
| Characteristic | New Device | Predicate Device | Predicate Device | Similar/Different |
| Strive | ||||
| Pre Warmup60 V @ 500 Ω165 V @ 2 kΩ165 V @ 10 kΩ | Pre Warmup60 V @ 500 Ω165 V @ 2 kΩ165 V @ 10 kΩ | Same asCompexWireless USADifferent fromStrive | ||
| Muscle Relaxation:60 V @ 500 Ω165 V @ 2 kΩ165 V @ 10 kΩ | Muscle Relaxation:60 V @ 500 Ω165 V @ 2 kΩ165 V @ 10 kΩ | Same asCompexWireless USADifferent fromStrive | ||
| Maximum Output Current(± 10%) | Pain Relief TENS:180[V] peak on 10[kΩ]170[V] peak on 2[kΩ]58[V] peak on 500[Ω] | 110[V] peak on 10[kΩ]110[V] peak on 2[kΩ]30[V] peak on 500[Ω] | Different fromStrive and fromCompexWireless USA | |
| Endurance:116 mA @ 500 Ω80 mA @ 2 kΩ15 mA @ 10 kΩ | Endurance:120 mA @ 500 Ω84 mA @ 2 kΩ14 mA @ 10 kΩ | Same asCompexWireless USADifferent fromStrive | ||
| Basic Unit Characteristics - Comparison with Predicate Device | ||||
| Characteristic | New Device | Predicate Device | Predicate Device | Similar/Different |
| Resistance:116 mA @ 500 Ω80 mA @ 2 kΩ17 mA @ 10 kΩ | Resistance:120 mA @ 500 Ω82 mA @ 2 kΩ17 mA @ 10 kΩ | Same asCompexWireless USADifferent fromStrive | ||
| Strength:113 mA @ 500 Ω80 mA @ 2 kΩ15 mA @ 10 kΩ | Strength:120 mA @ 500 Ω82 mA @ 2 kΩ18 mA @ 10 kΩ | Same asCompexWireless USADifferent fromStrive | ||
| Explosive Strength:81 mA @ 500 Ω81 mA @ 2 kΩ15 mA @ 10 kΩ | Explosive Strength:84 mA @ 500 Ω82 mA @ 2 kΩ18 mA @ 10 kΩ | Same asCompexWireless USADifferent fromStrive | ||
| Potentiation:117 mA @ 500 Ω80 mA @ 2 kΩ16 mA @ 10 kΩ | Potentiation:120 mA @ 500 Ω76 mA @ 2 kΩ13 mA @ 10 kΩ | Same asCompexWireless USADifferent fromStrive | ||
| Basic Unit Characteristics - Comparison with Predicate Device | ||||
| Characteristic | New Device | Predicate Device | Predicate Device | Similar/Different |
| Training Recovery: | Active Recovery: | Same as | ||
| 116 mA @ 500 Ω | 120 mA @ 500 Ω | Compex | ||
| 81mA @ 2 kΩ | 83 mA @ 2 kΩ | Wireless USA | ||
| 16 mA @ 10 kΩ | 18 mA @ 10 kΩ | Different from | ||
| Strive | ||||
| Competition Recovery: | Competition | Same as | ||
| Recovery: | Compex | |||
| 116 mA @ 500 Ω | 120 mA @ 500 Ω | Wireless USA | ||
| 81 mA @ 2 kΩ | 82 mA @ 2 kΩ | Different from | ||
| 16 mA @ 10 kΩ | 18 mA @ 10 kΩ | Strive | ||
| Pre Warmup | Pre Warmup | Same as | ||
| 116 mA @ 500 Ω | 120 mA @ 500 Ω | Compex | ||
| 81 mA @ 2 kΩ | 83 mA @ 2 kΩ | Wireless USA | ||
| 15 mA @ 10 kΩ | 18 mA @ 10 kΩ | Different from | ||
| Strive | ||||
| Muscle Relaxation: | Muscle Relaxation: | Same as | ||
| 116 mA @ 500 Ω | 120 mA @ 500 Ω | Compex | ||
| 81 mA @ 2 kΩ | 80mA @ 2 kΩ | Wireless USA | ||
| 16 mA @ 10 kΩ | 16 mA @ 10 kΩ | Different from | ||
| Strive | ||||
| Pain Relief TENS: | 12[mA] peak @10[kΩ] | Different from | ||
| 18[mA] peak @10[kΩ] | 55[mA] peak@2[kΩ] | Strive and from | ||
| 86[mA] peak@2[kΩ] | 60[mA] peak@500[Ω] | Compex | ||
| Basic Unit Characteristics – Comparison with Predicate Device | ||||
| Characteristic | New Device | Predicate Device | Predicate Device | Similar/Different |
| Pulse Width | 116[mA] peak@500[Ω] | Wireless USA | ||
| Endurance:200 to 400 [μs] | Endurance:200 to 400 [μs] | Same asCompexWireless USADifferent fromStrive | ||
| Resistance:200 to 400 [μs] | Resistance:200 to 400 [μs] | Same asCompexWireless USADifferent fromStrive | ||
| Strength:200 to 400 [μs] | Strength:200 to 400 [μs] | Same asCompexWireless USADifferent fromStrive | ||
| Explosive Strength:200 to 400 [μs] | Explosive Strength:200 to 400 [μs] | Same asCompexWireless USADifferent fromStrive | ||
| Potentiation:200 to 400 [μs] | Potentiation:200 to 400 [μs] | Same asCompexWireless USADifferent fromStrive | ||
| Basic Unit Characteristics – Comparison with Predicate Device | ||||
| Characteristic | New Device | Predicate Device | Similar/Different | |
| Training Recovery: | 200 to 400 [µs] | Training Recovery:200 to 400 [µs] | Same asCompexWireless USADifferent fromStrive | |
| Competition Recovery: | 200 to 400 [µs] | CompetitionRecovery:200 to 400 [µs] | Same asCompexWireless USADifferent fromStrive | |
| Pre Warmup | 200 to 400 [µs] | Pre Warmup200 to 400 [µs] | Same asCompexWireless USADifferent fromStrive | |
| Muscle Relaxation: | 200 to 400 [µs] | Muscle Relaxation:200 to 400 [µs] | Same asCompexWireless USADifferent fromStrive | |
| Pain Relief TENS: | 70 to 300[µs] (measuredat 50% of positive pulse) | 70 to 300[us] (measuredat 50% of positivepulse) | Same as Strive,different fromCompexWireless USA | |
| Basic Unit Characteristics – Comparison with Predicate Device | ||||
| Characteristic | New Device | Predicate Device | Similar/Different | |
| Frequency | Endurance:10 [Hz] | Endurance:10 [Hz] | Same asCompexWireless USADifferent fromStrive | |
| Resistance:50 [Hz] | Resistance:50 [Hz] | Same asCompexWireless USADifferent fromStrive | ||
| Strength:75 [Hz] | Strength:75 [Hz] | Same asCompexWireless USADifferent fromStrive | ||
| Explosive Strength:100 [Hz] | Explosive Strength:100 [Hz] | Same asCompexWireless USADifferent fromStrive | ||
| Potentiation:From 1 to 75 [Hz] | Potentiation:From 1 to 75 [Hz] | Same asCompexWireless USADifferent fromStrive | ||
| Characteristic | New Device | Predicate Device | Predicate Device | Similar/Different |
| Training Recovery: | 10 [Hz] | 10 [Hz] | Same asCompexWireless USADifferent fromStrive | |
| Competition Recovery: | 0.5 [Hz] | 0.5 [Hz] | Same asCompexWireless USADifferent fromStrive | |
| Pre Warmup | 4 [Hz] | 4 [Hz] | Same asCompexWireless USADifferent fromStrive | |
| Muscle Relaxation: | 1 [Hz] | 1 [Hz] | Same asCompexWireless USADifferent fromStrive | |
| Pain Relief TENS: | 5 to 122[Hz] | 5 to 122[Hz] | Same as Strive,different fromCompexWireless USA | |
| Basic Unit Characteristics – Comparison with Predicate Device | ||||
| Characteristic | New Device | Predicate Device | Predicate Device | Similar/Different |
| Net Charge [µC/pulse] | Endurance:0 [µC] @ 500ΩExcitation pulse fullycompensated | Endurance:0 [µC] @ 500ΩExcitation pulse fullycompensated | Same asCompexWireless USADifferent fromStrive | |
| Resistance:0 [µC] @ 500ΩExcitation pulse fullycompensated | Resistance:0 [µC] @ 500ΩExcitation pulse fullycompensated | Same asCompexWireless USADifferent fromStrive | ||
| Strength:0 [µC] @ 500ΩExcitation pulse fullycompensated | Strength:0 [µC] @ 500ΩExcitation pulse fullycompensated | Same asCompexWireless USADifferent fromStrive | ||
| Explosive Strength:0 [µC] @ 500ΩExcitation pulse fullycompensated | Explosive Strength:0 [µC] @ 500ΩExcitation pulse fullycompensated | Same asCompexWireless USADifferent fromStrive | ||
| Potentiation:0 [µC] @ 500ΩExcitation pulse fully | Potentiation:0 [µC] @ 500ΩExcitation pulse fully | Same asCompexWireless USADifferent fromStrive | ||
| Basic Unit Characteristics – Comparison with Predicate Device | ||||
| Characteristic | New Device | Predicate Device | Predicate Device | Similar/Different |
| compensated | compensated | Different fromStrive | ||
| Training Recovery:$0 [μC] @ 500Ω$Excitation pulse fullycompensated | Training Recovery:$0 [μC] @ 500Ω$Excitation pulse fullycompensated | Same asCompexWireless USADifferent fromStrive | ||
| Competition Recovery:$0 [μC] @ 500Ω$Excitation pulse fullycompensated | CompetitionRecovery:$0 [μC] @ 500Ω$Excitation pulse fullycompensated | Same asCompexWireless USADifferent fromStrive | ||
| Pre Warmup$0 [μC] @ 500Ω$Excitation pulse fullycompensated | Pre Warmup$0 [μC] @ 500Ω$Excitation pulse fullycompensated | Same asCompexWireless USADifferent fromStrive | ||
| Muscle Relaxation:$0 [μC] @ 500Ω$Excitation pulse fullycompensated | Muscle Relaxation:$0 [μC] @ 500Ω$Excitation pulse fullycompensated | Same asCompexWireless USADifferent fromStrive |
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| Basic Unit Characteristics - Comparison with Predicate Device | |||||||
|---|---|---|---|---|---|---|---|
| Characteristic | New Device | Predicate Device | Predicate Device | Similar/Different | |||
| Pain Relief TENS:0 [μC] @ 500ΩExcitation pulse fullycompensated | 18[uC] on 1[kΩ] | Different fromCompexWireless USAand Strive | |||||
| Maximum Phase Charge[uC] | 48 [μC] @ 500ΩSee detailed math below* | 48 [µC] @ 500Ω | 0[uC] on 1[kΩ] | Same asCompexWireless USADifferent fromStrive | |||
| Maximum CurrentDensity [mA/cm2] | 4.8 [mA/cm2] @ 500ΩSee detailed math below* | 4.8 [mA/cm2] @500Ω | 0.31[mA/cm2] (over1[s] period) | Same asCompexWireless USADifferent fromStrive | |||
| Maximum Power Density[mW/cm²] | 27.6 [mW/cm4] @ 500ΩSee detailed math below* | 27.6 [mW/cm2] @500Ω | 4.92[mW/cm2](split on 2x1[kΩ] in //) | Same asCompexWireless USADifferent fromStrive |
Although there are minor differences observed between the predicate devices, those differences do not raise any question in regards to safety and effectiveness.
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Performance Testing:
Electrical Safety and Electromagnetic Compatibility: The Compex Wireless USA was tested and found to comply with the following standards for electrical safety and electromagnetic compatibility.
FCC Radio Frequency Testing: The Compex Wireless USA was tested to FCC requirements and found to comply with the requirements of 47 CFR 15.249.
Software Verification: The device's software was verified in accordance with the requirements of FDA's guidance document: General Principles of Software Validation, January 11, 2002. The software testing demonstrated that the software meets its design requirements.
Usability/Human Factors Testing: Usability/Human Factors testing was performed, which demonstrated that the established requirements for usability were met, and the device's design is appropriate for the intended users and use environment. The result of this study substantiates the acceptability of the use-related risks identified during the risk assessment activities.
Wireless Coexistence Testing: The performance of Compex Wireless USA was evaluated in an environment with other Compex Wireless USA device and with other types of 2.4 GHz wireless devices (Bluetooth and Wi-Fi). The device met all specified requirements.
Standards:
The Compex Wireless USA conforms to the following standards:
- . AAMI/ANSI 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, Mod.). FDA Recognition No. 19-4.
- . IEC 60601-1-2 Edition 3:2007-03, Medical Electrical Equipment - Part 1 -2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests. FDA Recognition No. 19-1.
- . IEC 60601-1-6 Edition 3.1 2013-10. Medical Electrical Equipment - Part 1-6: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability. FDA Recognition No. 5-89.
- IEC 60601-1-11 Edition 1.0 2010-04, Medical Electrical Equipment Part 1-11: General . Requirements - Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment. FDA Recognition No. 19-6.
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- . IEC 60601-2-10 Edition 2.0 2012-06, Medical Electrical Equipment - Part 2-10: Particular Requirements for the Basic Safety and Essential Performance of Nerve and Muscle Stimulators. FDA Recognition No. 17-11.
- . IEC 62366 Edition 1.1 2014-01 , Consolidated Version Medical Devices - Application Of Usability Engineering To Medical Devices. (General I (QS/RM)). FDA Recognition No. 5-87
- ISO 14971 Second Edition 2007-03-01. Medical Devices - Applications of Risk Management to Medical Devices. Recognition No. 5-40.
- . AAMI /ANSI /IEC 62304:2006, Medical Device Software - Software Life Cycle Processes. Recognition No. 13-32.
This submission does not contain clinical data.
Conclusion:
Based on the performance testing and the similarities of the indications for use and the technological characteristics, it can be concluded that the Compex Wireless USA is as safe and effective as, and substantially equivalent to, the predicate devices.
§ 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).