(333 days)
TENS: To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. PMS: It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
SM TENS & PMS is a portable and DC 3.7V battery powered multi function device, offering both Transcutancous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) qualities in one device. SM TENS & PMS has 6 operation modes, which can give certain electrical pulses through electrode adhesive pads to the suggested area of the body where the electrodes are placed. The electronic stimulatory module has the operating elements of ON/OFF Switch, Display screen, Mode Selection key, Intensity Modification keys, Timing key, Pause key, Output socket, and USB port for battery charging. The display screen can show battery power, selected mode, current intensity, time remaining of an application mode, and indication of a pause. The device is equipped with accessories of electrode pads, electrode cables, battery chargers, and USB cables. The electrode cables are used to connect the pads to the device; the USB cable is used to connect the charger and the built-in lithium battery. All accessories, including USB cables, electrode pads, electrode cables, chargers can only be changed by special person. The electrodes are interchangeable. The application area of electrode pads must be larger than 4cm². The electrode pads are provided by GMDASZ Manufacturing Co., Ltd. with 510(k) cleared Number K092546.
This submission is for a Traditional 510(k) for a new device, the "SM TENS & PMS" from Hong Qiangxing (Shen Zhen) Electronics Limited. The device is a portable, battery-powered multi-function device offering both Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) functionalities. The 510(k) submission seeks to demonstrate substantial equivalence to a predicate device, the "Powered Muscle Stimulator, JQ-5C" (K102598).
The acceptance criteria are established through a comparison of the new device's technical characteristics and performance against the predicate device and relevant safety standards. The study proving the device meets the acceptance criteria is a safety testing protocol, which demonstrates compliance with recognized electrical and medical device standards.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria, for the purpose of a 510(k) for substantial equivalence, are primarily that the new device performs equivalently to the predicate device in its intended use and meets relevant safety standards, without raising new questions of safety or effectiveness. The reported device performance is based on the results of the safety testing.
| Acceptance Criteria Category | Specific Acceptance Criteria (Derived from comparison to predicate and standards) | Reported Device Performance |
|---|---|---|
| Intended Use | Identical indications for use as the predicate device (TENS for temporary pain relief, PMS for muscle performance improvement). | Met: Both SM TENS & PMS and the predicate (JQ-5C) have identical TENS and PMS indications for use. |
| Technological Characteristics | Similar design, power source, number of output modes, number of output channels, synchronization, channel isolation method, timer range, waveform, and wave shape. | Met: The new device is reported to have the same intended use, power supply, components, 6 modes, 2 channels, software control, standards compliance, same waveform and wave shape, same pulse width, and net charge. |
| Electrical Safety | Compliance with IEC 60601-1 (General Safety), IEC 60601-2-10 (Nerve and Muscle Stimulators), and IEC 60601-1-2 (EMC). | Met: The new device passed testing according to IEC 60601-1: 2005, IEC 60601-2-10: 2001, and IEC 60601-1-2: 2001. |
| Battery Safety | Compliance with IEC 62133 (Secondary cells and batteries safety). | Met: The new device passed testing according to IEC 62133: 2002. |
| Electromagnetic Compatibility (EMC) | Compliance with FCC 47 CFR Part 18 (Industrial, Scientific, and Medical Equipment - Conducted Emissions). | Met: The new device passed testing according to FCC 47 CFR Part 18. |
| Output Parameters (Key electrical characteristics - variations within acceptable limits) | Maximum Output Voltage, Maximum Output Current, Pulse Width, Max. Pulse Frequency, Net Charge, Maximum Phase Charge, Maximum Average Current, Maximum Current Density, Maximum Average Power Density to be comparable or safer than predicate. | Met/Compared: While some specific numerical values differ (e.g., Maximum Output Voltage and Current, Max. Pulse Frequency, Maximum Current Density, Maximum Average Power Density), the submission concludes these differences (and those attributable to different smallest surface area of electrodes) do not raise new safety or effectiveness issues. Net charge and pulse width are the same. |
| Patient Leakage Current | Normal Condition: ≤ 2μA; Single Fault Condition: |
§ 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).