Description
Description of Device
The MHD TENS is a portable, battery-powered dual-function device that combines Transcutaneous Electrical Nerve Stimulation (TENS) and Powered Muscle Stimulation (PMS). It delivers electrical pulses to the skin via adhesive electrode pads, providing pain relief and enhancing muscle performance.
The device includes:
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12 pre-programmed therapy modes
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A user interface with an LCD screen displaying time, intensity, program, and battery level
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Touchscreen operation supported by a screen stylus
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Intensity adjustment buttons, a screen lock button, and USB charging capability
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Accessories: electrode pads, electrode wires, USB cable, charger, and stylus
It is powered by a rechargeable 3.7V lithium battery and designed for over-the-counter (OTC) use in home or clinical settings.
Intended Use
The MHD TENS device has two distinct therapeutic functions, based on the selected program:
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Transcutaneous Electrical Nerve Stimulation (Programs 2, 3, 4, 6, 8, 9):
Intended for the temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arms (upper extremities), and legs (lower extremities) due to strain from exercise or everyday household activities. -
Powered Muscle Stimulation (Programs 1, 5, 7, 10, 11, 12):
Intended to stimulate healthy muscles to improve and facilitate muscle performance.
Technological Characteristics
The MHD TENS shares fundamental design and functional elements with its predicate device (TENS and Powered Muscle Stimulator, K143268), but includes some enhancements:
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Stimulation Type: Symmetric, biphasic, pulsed waveforms with adjustable frequency and intensity
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Channels: Dual-channel, alternating output
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Programs: 12 therapy modes (6 TENS and 6 PMS), offering broader treatment customization than the predicate
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Power Source: Rechargeable 3.7V lithium battery
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Control Interface: Touchscreen LCD with lock function and stylus, offering enhanced usability
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Safety Features:
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Balanced waveform (0 μC net charge per pulse)
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Automatic shut-off
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Software-controlled parameters
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Electrical isolation (Type BF applied part)
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The device complies with applicable electrical safety and electromagnetic compatibility standards, including:
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ANSI AAMI ES60601-1
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IEC 60601-2-10
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IEC 60601-1-11 (home healthcare)
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IEC 60601-1-2 (EMC)
Although differences exist in waveform parameters (e.g., max voltage, current, frequency), all variations fall within the safe performance thresholds established by IEC standards. Therefore, the MHD TENS is deemed substantially equivalent in safety and effectiveness to its predicate.