(263 days)
The Transcutaneous Electrical Nerve Stimulator 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. In particular, this device is indicated for use for symptomatic relief of chronic intractable pain and adjunctive treatment of post surgical and post traumatic pain.
Transcutaneous Electrical Nerve Stimulator is Transcutaneous Electrical Nerve Stimulator for pain relief. The stimulator sends gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin. The device has standard programs and edit programs. It is a battery-powered portable device, comprising electronic stimulatory module and accessories of lead wires, electrodes and battery. Two outlet sockets are used to connect skin electrodes by lead wires. The accessories of electrodes is 510(k) cleared device (K192568), Size: 50*50mm.
This document is a 510(k) Premarket Notification for a Transcutaneous Electrical Nerve Stimulator (TENS) device. The purpose of this submission is to demonstrate that the new device, "TENStem eco basic," is substantially equivalent to a legally marketed predicate device (K112288), also a TENS device manufactured by the same company, Wuxi Jiajian Medical Instrument Co., Ltd.
Here's an analysis of the provided information regarding acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the parameters of the predicate device (K112288) and the relevant IEC standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10). The reported device performance is presented as a comparison between the proposed device ("Modified Device") and the predicate device in the "Substantially Equivalent Comparison Conclusion" table.
| Parameter | Acceptance Criteria (Predicate Device K112288) | Reported Device Performance (TENStem eco basic) | Remark (Meeting Criteria) |
|---|---|---|---|
| Intended Use | Same | Same | Met |
| Type of Use | Prescription use | Prescription use | Met |
| Power Source(s) | 9V Battery type 6F22 | 1.5Vx4 AAA alkaline battery | Similar (Note 1) |
| Method of Line Current Isolation | NA | N/A | Met |
| Patient Leakage Current - Normal Condition (μΑ) | 2μΑ | 2μΑ | Met |
| Patient Leakage Current - Single Fault Condition (μΑ) | NA | NA | Met |
| Average DC current through electrodes when device is on but no pulses are being applied (μΑ) |
§ 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).