(243 days)
It is intended to be used for temporary relief of pain associated with sore and aching muscle in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
The TENS is an electrical nerve stimulator indicated for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain.
The TENS consists of LCD, Control Key, Switch, Battery, Output jack and USB port, its accessories includes electrode, electrode cable, USB wire and Battery charger. Only the electrode pads cleared in submission, K092546, are to be used with this device
The proposed device has six models: SM9066, SM9088, SM9090, SM9098, SM9128 and SM9198. The six models have the same design principle and functional components, including battery, LCD, Control Key, Switch, channel number and USB port and accessories. The difference between the six models specifically expressed in the battery specification, LCD dimension, the position of Control key, Switch, and USB port on the proposed device, PCB(Printed Circuit Board) dimension and the number of Output jack numbers.
This document describes a 510(k) submission for Transcutaneous Electrical Nerve Stimulator (TENS) devices. It focuses on demonstrating substantial equivalence to a predicate device, rather than a standalone study proving a device meets specific acceptance criteria based on clinical outcomes or accuracy metrics for a diagnostic device.
Therefore, much of the requested information regarding acceptance criteria, reported performance, sample sizes for test/training sets, expert ground truth, adjudication methods, and MRMC studies is not directly applicable or available in this type of regulatory submission. This document is a premarket notification (510(k)), which aims to demonstrate that a new device is as safe and effective as a legally marketed predicate device, not necessarily to prove efficacy through a clinical trial with acceptance criteria for performance.
However, I can extract information related to the device's technical specifications and the testing done to support its substantial equivalence.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (implicit from comparison to predicate and standards): The implicit acceptance criteria are that the device's technological characteristics are substantially equivalent to the predicate device and that it complies with relevant electrical safety and EMC standards. Specifically, for electrical output parameters, the proposed device's values should be covered by or deemed substantially equivalent to the predicate's values. For current/frequency, they must also meet IEC 60601-2-10 limits.
- Reported Device Performance:
| Parameter | Proposed Device Performance (TENS Models SM9066, SM9088, SM9090, SM9098, SM9128, SM9198) | Predicate Device Performance (JQ-5C, K102598) | Acceptance/Comparison Justification |
|---|---|---|---|
| Power source | DC 3.7V Lithium Battery | DC 3.7V Lithium Battery | Same |
| Waveform | Pulse, biphasic | Pulse, biphasic | Same |
| Shape | Rectangular | Rectangular | Same |
| Pulse Duration (Pulse width) | 100µs | 100µs | Same |
| Net Charge | 0 µC@500Ω, balanced waveform | 0 µC@500Ω, balanced waveform | Same |
| Maximum Output Voltage | 42V ± 10%@500Ω, 84V±10%@2kΩ, 140V ± 10%@10kΩ | 62.4V@500Ω, 79.2V@2.2kΩ, 84V%@10kΩ | Proposed device's maximum output voltage is stated to be "covered by that of the predicate device" (despite higher 10kΩ value, this comment refers to the comparative safety profile) and considered substantially equivalent. |
| Maximum Output Current | 84mA±10%@500Ω, 42mA±10%@2kΩ, 14mA±10%@10kΩ | 124.8mA@500Ω, 39.65mA@2.2kΩ, 8.4 mA@10kΩ | Similarly, proposed device's maximum output current is stated to be "also covered by that of the predicate device" and considered substantially equivalent. |
| Frequency | 68Hz, 12.5~55.5 Hz, 1.17 Hz, 5.8 Hz, 108 Hz, 29 Hz | Similar | Slight difference but "considered to be acceptable and substantially equivalent" as RMS output current meets IEC 60601-2-10 requirements ( |
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).