(83 days)
Not Found
No
The summary describes a standard electrical stimulation device (NMES/TENS) with wireless control. There is no mention of AI or ML in the intended use, device description, or performance studies. The software validation is described as meeting design requirements, which is typical for medical device software and does not imply AI/ML.
Yes
The device is described as "Compex Wireless USA as a TENS device" and explicitly states its use 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 applications.
No
The device description explicitly states that the Compex Wireless USA is not intended for adjunctive therapy in the treatment of medical diseases and conditions, nor is it designed for injured or disease-afflicted muscles. Its primary functions are muscle stimulation for performance, pain relief (TENS), and muscle training (NMES), none of which involve diagnosing medical conditions.
No
The device description explicitly states that the system is made up of a remote control, stimulation modules, electrodes, and a docking station, all of which are hardware components. The software runs on these hardware components to control the electrical stimulation.
Based on the provided text, the Compex Wireless USA is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for stimulating healthy muscles to improve performance and for temporary pain relief. It explicitly states it's not intended for adjunctive therapy in the treatment of medical diseases and conditions.
- Device Description: The device description details its function as an electrical stimulator (NMES and TENS) that works by applying electrical impulses to nerves and muscles. This is an external physical interaction, not an in vitro test of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, the Compex Wireless USA is a medical device, but it falls under the category of electrical stimulators for muscle performance and pain relief, not in vitro diagnostics.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
NGX, NUH, NYN
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Muscles
Indicated Patient Age Range
Adults only.
Intended User / Care Setting
Over-The-Counter use.
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)
Performance testing included: Electrical Safety and Electromagnetic Compatibility (Complying with AAMI/ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 and IEC 60601-1-2 Edition 3:2007-03), FCC Radio Frequency Testing (Complying with 47 CFR 15.249), Software Verification (in accordance with FDA's guidance document: General Principles of Software Validation, January 11, 2002; demonstrated software meets design requirements), Usability/Human Factors Testing (demonstrated requirements were met and design appropriate for intended users/environment, substantiating acceptability of use-related risks; complying with IEC 60601-1-6 Edition 3.1 2013-10 and IEC 62366 Edition 1.1 2014-01), and Wireless Coexistence Testing (evaluated performance in environment with other Compex Wireless USA devices and 2.4 GHz wireless devices (Bluetooth and Wi-Fi); device met all specified requirements). No clinical data was included in the submission.
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 Wireless USA (K143551), Strive (K153704)
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/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
2
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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3
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, LLC
1430 Decision Street
Vista, CA 92081 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Neeta Sharma
Sr. Director, Regulatory Affairs
760-734-3551 |
| 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 890.5850
Product Code NGX; Review Panel: Physical Medicine
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 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 | |
| Competition | ||
| Recovery | 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:
7
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 wires | |||
| Stimulation 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 wires | |||
| Stimulation 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 remains | ||||
| fully managed by | ||||
| Stimulation Module | ||||
| electronic circuit itself. | Modules. Stimulation | |||
| safety remains fully | ||||
| managed by Stimulation | ||||
| Module electronic | ||||
| circuit itself. | ||||
| Power Sources | Remote: : Lithium | |||
| Polymer (LiPo) | ||||
| rechargeable 3.7[V] / ≥ | ||||
| 1500[mAh] | ||||
| Stimulation Modules: | ||||
| Lithium Polymer (LiPo) | ||||
| rechargeable 3.7[V] / ≥ | ||||
| 450[mAh] | Remote: : Lithium | |||
| Polymer (LiPo) | ||||
| rechargeable 3.7[V] / ≥ | ||||
| 1500[mAh] | ||||
| Stimulation Modules: | ||||
| Lithium Polymer | ||||
| (LiPo) rechargeable | ||||
| 3.7[V] / ≥ 450[mAh] | LiPo 250 [mAh] (3.7[V]), | |||
| not removable | Same as Compex | |||
| Wireless USA | ||||
| Different from | ||||
| Strive | ||||
| Method of line current | ||||
| isolation | N/A (battery operated | |||
| device) | N/A (battery operated | |||
| device) | N/A (battery operated | |||
| device) | Similar | |||
| Patient Leakage Current | N/A (battery operated | |||
| device) | N/A (battery | |||
| operated device) | N/A (battery | |||
| operated device) | Similar | |||
| • Normal condition | N/A (battery operated | |||
| device) | N/A (battery | |||
| operated device) | N/A (battery | |||
| operated device) | Similar | |||
| • Single fault | ||||
| condition | N/A (battery operated | |||
| device) | N/A (battery | |||
| operated device) | N/A (battery | |||
| operated 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 Compex |
| Wireless USA | ||||
| Different from | ||||
| Strive | ||||
| 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 channels | |||
| activated at the same | ||||
| time | never 2 channels | |||
| activated at the | ||||
| same time | Wireless USA | |||
| - Method of Channel | ||||
| Isolation | Each channel is the | |||
| middle of a H- Bridge. | ||||
| Except when it is | ||||
| activated, each channel is | ||||
| always in high | ||||
| impedance state. | Each channel is the | |||
| middle of a H- | ||||
| Bridge. Except when | ||||
| it is activated, each | ||||
| channel is always in | ||||
| high impedance state. | N/A | Same as Compex | ||
| Wireless USA | ||||
| Regulated Current or | ||||
| Regulated Voltage? | Regulated current (all | |||
| channels) | Regulated current (all | |||
| channels) | Regulated Current | Similar | ||
| Software/Firmware/Micropro | ||||
| cessor Control? | Yes | Yes | Yes | Similar |
| Automatic Overload Trip? | Yes | Yes | No | Same as Compex |
| Wireless 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 button | |||
| directly pause the program | Yes, push on On/Off button | |||
| directly pause the program | Yes, push on On/Off button | |||
| directly pause the program | Similar | |||
| Indicator Display |
- On/Off Status? | Yes | Yes | Yes | Similar |
| - Low Battery? | Yes | Yes | No | Same as Compex
Wireless 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 Strive
Same as Compex Wireless USA |
| Compliance with 21 CFR 898? | Yes | Yes | Yes | Different from Strive
Similar |
| 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 USA
Different 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 USA
Different from Strive |
| Basic Unit Characteristics – Comparison with Predicate Device | | | | |
| Characteristic | New Device | Predicate Device | Predicate Device | Similar/
Different |
| | Recovery (same as
Recovery Plus):
Symmetrical Biphasic | Symmetrical
Biphasic | | |
| | -Pre-Warmup Program:
Symmetrical Biphasic
-Muscle Relaxation (same
as Massage):
Symmetrical Biphasic | -Pre-Warmup Program:
Symmetrical Biphasic
-Massage:
Symmetrical Biphasic | | |
| | -Pain relief TENS (same
as FM): Balanced,
asymetrical Biphasic | | Balanced, Asymmetrical
Biphasic | Same as Strive
Different from
Compex Sport
Plus |
| Shape (program per
program) | -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 as
Compex
Wireless USA
Different from
Strive |
| Basic Unit Characteristics – Comparison with Predicate Device | | | | |
| Characteristic | New Device | Predicate Device | Predicate Device | Similar/
Different |
| | -Competition
Recovery:
Rectangular
-Pre-Warmup:
Rectangular
-Muscle Relaxation:
Rectangular | - Competition
Recovery:
Rectangular
-Pre-Warmup:
Rectangular - Muscle Relaxation:
Rectangular | | |
| | -Pain relief TENS (same
as FM): | | Square positive pulse,
current controlled
Logarithmic negative
pulse,decrease current | Same as Strive
Different from
Compex
Wireless USA |
| Maximum Output Voltage
(± 10%) | Endurance:
60 V @ 500 Ω
165 V @ 2 kΩ
165 V @ 10 kΩ | Endurance:
60 V @ 500 Ω
165 V @ 2 kΩ
165 V @ 10 kΩ | | Same as
Compex
Wireless USA
Different from
Strive |
| | Resistance:
60 V @ 500 Ω
165 V @ 2 kΩ
165 V @ 10 kΩ | Resistance:
60 V @ 500 Ω
165 V @ 2 kΩ
165 V @ 10 kΩ | | Same as
Compex
Wireless USA
Different from
Strive |
| | Strength:
60 V @ 500 Ω | Strength:
60 V @ 500 Ω | | Same as
Compex |
| Basic Unit Characteristics – Comparison with Predicate Device | | | | |
| Characteristic | New Device | Predicate Device | Predicate Device | Similar/
Different |
| | 165 V @ 2 kΩ
165 V @ 10 kΩ | 165 V @ 2 kΩ
165 V @ 10 kΩ | | Wireless USA
Different from
Strive |
| | Explosive Strength:
60 V @ 500 Ω
165 V @ 2 kΩ
165 V @ 10 kΩ | Explosive Strength:
60 V @ 500 Ω
165 V @ 2 kΩ
165 V @ 10 kΩ | | Same as
Compex
Wireless USA
Different from
Strive |
| | Potentiation:
60 V @ 500 Ω
152 V @ 2 kΩ
136 V @ 10 kΩ | Potentiation:
60 V @ 500 Ω
152 V @ 2 kΩ
136 V @ 10 kΩ | | Same as
Compex
Wireless USA
Different from
Strive |
| | Training Recovery:
60 V @ 500 Ω
165 V @ 2 kΩ
165 V @ 10 kΩ | Training Recovery :
60 V @ 500 Ω
165 V @ 2 kΩ
165 V @ 10 kΩ | | Same as
Compex
Wireless USA
Different from
Strive |
| | Competition Recovery:
60 V @ 500 Ω
165 V @ 2 kΩ
165 V @ 10 kΩ | CompetitionRecovery:
60 V @ 500 Ω
165 V @ 2 kΩ
165 V @ 10 kΩ | | Same as
Compex
Wireless USA
Different from
Strive |
| Basic Unit Characteristics – Comparison with Predicate Device | | | | |
| Characteristic | New Device | Predicate Device | Predicate Device | Similar/
Different |
| | | | | Strive |
| | Pre Warmup
60 V @ 500 Ω
165 V @ 2 kΩ
165 V @ 10 kΩ | Pre Warmup
60 V @ 500 Ω
165 V @ 2 kΩ
165 V @ 10 kΩ | | Same as
Compex
Wireless USA
Different from
Strive |
| | Muscle Relaxation:
60 V @ 500 Ω
165 V @ 2 kΩ
165 V @ 10 kΩ | Muscle Relaxation:
60 V @ 500 Ω
165 V @ 2 kΩ
165 V @ 10 kΩ | | Same as
Compex
Wireless USA
Different from
Strive |
| 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 from
Strive and from
Compex
Wireless USA |
| | Endurance:
116 mA @ 500 Ω
80 mA @ 2 kΩ
15 mA @ 10 kΩ | Endurance:
120 mA @ 500 Ω
84 mA @ 2 kΩ
14 mA @ 10 kΩ | | Same as
Compex
Wireless USA
Different from
Strive |
| Basic Unit Characteristics - Comparison with Predicate Device | | | | |
| Characteristic | New Device | Predicate Device | Predicate Device | Similar/
Different |
| | Resistance:
116 mA @ 500 Ω
80 mA @ 2 kΩ
17 mA @ 10 kΩ | Resistance:
120 mA @ 500 Ω
82 mA @ 2 kΩ
17 mA @ 10 kΩ | | Same as
Compex
Wireless USA
Different from
Strive |
| | Strength:
113 mA @ 500 Ω
80 mA @ 2 kΩ
15 mA @ 10 kΩ | Strength:
120 mA @ 500 Ω
82 mA @ 2 kΩ
18 mA @ 10 kΩ | | Same as
Compex
Wireless USA
Different from
Strive |
| | Explosive Strength:
81 mA @ 500 Ω
81 mA @ 2 kΩ
15 mA @ 10 kΩ | Explosive Strength:
84 mA @ 500 Ω
82 mA @ 2 kΩ
18 mA @ 10 kΩ | | Same as
Compex
Wireless USA
Different from
Strive |
| | Potentiation:
117 mA @ 500 Ω
80 mA @ 2 kΩ
16 mA @ 10 kΩ | Potentiation:
120 mA @ 500 Ω
76 mA @ 2 kΩ
13 mA @ 10 kΩ | | Same as
Compex
Wireless USA
Different from
Strive |
| 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 as
Compex
Wireless USA
Different from
Strive |
| | Resistance:
200 to 400 [μs] | Resistance:
200 to 400 [μs] | | Same as
Compex
Wireless USA
Different from
Strive |
| | Strength:
200 to 400 [μs] | Strength:
200 to 400 [μs] | | Same as
Compex
Wireless USA
Different from
Strive |
| | Explosive Strength:
200 to 400 [μs] | Explosive Strength:
200 to 400 [μs] | | Same as
Compex
Wireless USA
Different from
Strive |
| | Potentiation:
200 to 400 [μs] | Potentiation:
200 to 400 [μs] | | Same as
Compex
Wireless USA
Different from
Strive |
| 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 as
Compex
Wireless USA
Different from
Strive | |
| Competition Recovery: | 200 to 400 [µs] | Competition
Recovery:
200 to 400 [µs] | Same as
Compex
Wireless USA
Different from
Strive | |
| Pre Warmup | 200 to 400 [µs] | Pre Warmup
200 to 400 [µs] | Same as
Compex
Wireless USA
Different from
Strive | |
| Muscle Relaxation: | 200 to 400 [µs] | Muscle Relaxation:
200 to 400 [µs] | Same as
Compex
Wireless USA
Different from
Strive | |
| Pain Relief TENS: | 70 to 300[µs] (measured
at 50% of positive pulse) | 70 to 300[us] (measured
at 50% of positive
pulse) | Same as Strive,
different from
Compex
Wireless USA | |
| Basic Unit Characteristics – Comparison with Predicate Device | | | | |
| Characteristic | New Device | Predicate Device | Similar/Different | |
| Frequency | Endurance:
10 [Hz] | Endurance:
10 [Hz] | Same as
Compex
Wireless USA
Different from
Strive | |
| | Resistance:
50 [Hz] | Resistance:
50 [Hz] | Same as
Compex
Wireless USA
Different from
Strive | |
| | Strength:
75 [Hz] | Strength:
75 [Hz] | Same as
Compex
Wireless USA
Different from
Strive | |
| | Explosive Strength:
100 [Hz] | Explosive Strength:
100 [Hz] | Same as
Compex
Wireless USA
Different from
Strive | |
| | Potentiation:
From 1 to 75 [Hz] | Potentiation:
From 1 to 75 [Hz] | Same as
Compex
Wireless USA
Different from
Strive | |
| Characteristic | New Device | Predicate Device | Predicate Device | Similar/
Different |
| Training Recovery: | 10 [Hz] | 10 [Hz] | | Same as
Compex
Wireless USA
Different from
Strive |
| Competition Recovery: | 0.5 [Hz] | 0.5 [Hz] | | Same as
Compex
Wireless USA
Different from
Strive |
| Pre Warmup | 4 [Hz] | 4 [Hz] | | Same as
Compex
Wireless USA
Different from
Strive |
| Muscle Relaxation: | 1 [Hz] | 1 [Hz] | | Same as
Compex
Wireless USA
Different from
Strive |
| Pain Relief TENS: | 5 to 122[Hz] | | 5 to 122[Hz] | Same as Strive,
different from
Compex
Wireless USA |
| Basic Unit Characteristics – Comparison with Predicate Device | | | | |
| Characteristic | New Device | Predicate Device | Predicate Device | Similar/
Different |
| Net Charge [µC/pulse] | Endurance:
0 [µC] @ 500Ω
Excitation pulse fully
compensated | Endurance:
0 [µC] @ 500Ω
Excitation pulse fully
compensated | | Same as
Compex
Wireless USA
Different from
Strive |
| | Resistance:
0 [µC] @ 500Ω
Excitation pulse fully
compensated | Resistance:
0 [µC] @ 500Ω
Excitation pulse fully
compensated | | Same as
Compex
Wireless USA
Different from
Strive |
| | Strength:
0 [µC] @ 500Ω
Excitation pulse fully
compensated | Strength:
0 [µC] @ 500Ω
Excitation pulse fully
compensated | | Same as
Compex
Wireless USA
Different from
Strive |
| | Explosive Strength:
0 [µC] @ 500Ω
Excitation pulse fully
compensated | Explosive Strength:
0 [µC] @ 500Ω
Excitation pulse fully
compensated | | Same as
Compex
Wireless USA
Different from
Strive |
| | Potentiation:
0 [µC] @ 500Ω
Excitation pulse fully | Potentiation:
0 [µC] @ 500Ω
Excitation pulse fully | | Same as
Compex
Wireless USA
Different from
Strive |
| Basic Unit Characteristics – Comparison with Predicate Device | | | | |
| Characteristic | New Device | Predicate Device | Predicate Device | Similar/
Different |
| | compensated | compensated | | Different from
Strive |
| Training Recovery:
$0 [μC] @ 500Ω$
Excitation pulse fully
compensated |
| Training Recovery:
$0 [μC] @ 500Ω$
Excitation pulse fully
compensated | | Same as
Compex
Wireless USA
Different from
Strive |
| Competition Recovery:
$0 [μC] @ 500Ω$
Excitation pulse fully
compensated | | Competition
Recovery:
$0 [μC] @ 500Ω$
Excitation pulse fully
compensated | | Same as
Compex
Wireless USA
Different from
Strive |
| Pre Warmup
$0 [μC] @ 500Ω$
Excitation pulse fully
compensated | | Pre Warmup
$0 [μC] @ 500Ω$
Excitation pulse fully
compensated | | Same as
Compex
Wireless USA
Different from
Strive |
| Muscle Relaxation:
$0 [μC] @ 500Ω$
Excitation pulse fully
compensated | | Muscle Relaxation:
$0 [μC] @ 500Ω$
Excitation pulse fully
compensated | | Same as
Compex
Wireless USA
Different from
Strive |
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
| Basic Unit Characteristics - Comparison with Predicate Device | |||||||
|---|---|---|---|---|---|---|---|
| Characteristic | New Device | Predicate Device | Predicate Device | Similar/ | |||
| Different | |||||||
| Pain Relief TENS: | |||||||
| 0 [μC] @ 500Ω | |||||||
| Excitation pulse fully | |||||||
| compensated | 18[uC] on 1[kΩ] | Different from | |||||
| Compex | |||||||
| Wireless USA | |||||||
| and Strive | |||||||
| Maximum Phase Charge | |||||||
| [uC] | 48 [μC] @ 500Ω | ||||||
| See detailed math below* | 48 [µC] @ 500Ω | 0[uC] on 1[kΩ] | Same as | ||||
| Compex | |||||||
| Wireless USA | |||||||
| Different from | |||||||
| Strive | |||||||
| Maximum Current | |||||||
| Density [mA/cm2] | 4.8 [mA/cm2] @ 500Ω | ||||||
| See detailed math below* | 4.8 [mA/cm2] @ | ||||||
| 500Ω | 0.31[mA/cm2] (over | ||||||
| 1[s] period) | Same as | ||||||
| Compex | |||||||
| Wireless USA | |||||||
| Different from | |||||||
| Strive | |||||||
| Maximum Power Density | |||||||
| [mW/cm²] | 27.6 [mW/cm4] @ 500Ω | ||||||
| See detailed math below* | 27.6 [mW/cm2] @ | ||||||
| 500Ω | 4.92[mW/cm2] | ||||||
| (split on 2x1[kΩ] in //) | Same as | ||||||
| Compex | |||||||
| Wireless USA | |||||||
| Different from | |||||||
| Strive |
Although there are minor differences observed between the predicate devices, those differences do not raise any question in regards to safety and effectiveness.
24
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.
25
- . 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.