(90 days)
No
The description focuses on basic electrical stimulation parameters, battery life, and user interface elements. There is no mention of adaptive algorithms, learning from data, or any features typically associated with AI/ML.
Yes
The device is described as an Electrical Muscle Stimulator intended for medical purposes that repeatedly contracts muscles, which is a therapeutic function.
No
The device description clearly states it is an "Electrical Muscle Stimulator" intended for medical purposes that repeatedly contracts muscles by passing electrical currents. Its function is to stimulate muscles, not to diagnose a condition.
No
The device description explicitly details hardware components such as electrodes, housing, LEDs, a dial, and batteries, indicating it is a physical device with electrical stimulation capabilities, not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device "repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area." This is a physical interaction with the body, not an analysis of a biological specimen.
- Intended Use: The intended use is for "medical purposes that repeatedly contracts muscles," which aligns with a therapeutic or rehabilitative function, not diagnostic testing of samples.
The device described is an Electrical Muscle Stimulator (EMS), which is a type of medical device used for therapeutic purposes, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The MuscleMax™ Plus is a disposable single patient use (Electrical Muscle Stimulator) intended for medical ਲਿਖਿਟ purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.
Product codes
Not Found
Device Description
The MuscleMax™ Plus is a disposable single patient use (Electrical Muscle Stimulator) intended for medical ਲਿਖਿਟ purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area. The output waveform consists of a 2200Hz biphasic, symmetrical one period signal (zero net DC component) in a series of low frequency (72 pps) bursts. Testing confirmed the device to fall within the acceptance criteria of 75uC for maximum charge per pulse when tested with a 500, 2K, and 10K Ohm load and the functional battery life of the device to exceed the minimum specification of 100 hours at maximum intensity. Because the wave is an alternating current, there is no net polar effects to cause long-term positive ion concentrations within the tissues beneath either electrode. The ON/OFF and intensity functions are controlled with a dial into the housing to reduce the potential recessed for inadvertent changes in intensity or accidental turning ON of the device. The unit has a green LED indicating when the unit is ON and releasing an electrical current, and a yellow LED indicating the unit is in the 20 second OFF cycle and will begin to release an electrical current within 20 seconds. The yellow LED warns the user not to increase the intensity until the green LED is illuminated to avoid inadvertent increases in output. The device is supplied with pre-gelled conductive electrode pads which have been cleared for marketing by the Food and Drug Administration under K912461. The electrode leads are strain relieved and designed to remain securely attached to the device (not removable), reducing the potential for attaching to AC power lines. The device is powered by four (4) 1.5 volt DC batteries contained within the housing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
affected body area
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Testing confirmed the device to fall within the acceptance criteria of 75uC for maximum charge per pulse when tested with a 500, 2K, and 10K Ohm load and the functional battery life of the device to exceed the minimum specification of 100 hours at maximum intensity.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
SEP 2 3 1996
Smith & Nephew DonJoy Inc.
2777 Loker Avenue West Carlsbad, CA 92008-6601 U.S.A Telephone: (619) 438-9091 Toll-free (800) 336-5690 Telefax: (619) 438-3210
Smith+Nephew
K. SUMMARY OF SAFETY AND ERECHINGINESS.
The MuscleMax™ Plus is a disposable single patient use (Electrical Muscle Stimulator) intended for medical ਲਿਖਿਟ purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area. The output waveform consists of a 2200Hz biphasic, symmetrical one period signal (zero net DC component) in a series of low frequency (72 pps) bursts. Testing confirmed the device to fall within the acceptance criteria of 75uC for maximum charge per pulse when tested with a 500, 2K, and 10K Ohm load and the functional battery life of the device to exceed the minimum specification of 100 hours at maximum intensity. Because the wave is an alternating current, there is no net polar effects to cause long-term positive ion concentrations within the tissues beneath either electrode. The ON/OFF and intensity functions are controlled with a dial into the housing to reduce the potential recessed for inadvertent changes in intensity or accidental turning ON of the device. The unit has a green LED indicating when the unit is ON and releasing an electrical current, and a yellow LED indicating the unit is in the 20 second OFF cycle and will begin to release an electrical current within 20 seconds. The yellow LED warns the user not to increase the intensity until the green LED is illuminated to avoid inadvertent increases in output. The device is supplied with pre-gelled conductive electrode pads which have been cleared for marketing by the Food and Drug Administration under K912461. The electrode leads are strain relieved and designed to remain securely attached to the device (not removable), reducing the potential for attaching to AC power lines. The device is powered by four (4) 1.5 volt DC batteries contained within the housing.
Smith & Nephew DonJoy Inc.
Dan W. Miller 6-21-96
Dan W. Miller Director of Regulatory Affairs and Quality Assurance
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