(86 days)
The Transcutaenous Electrical Nerve Stimulator (Model RJTENS-1) 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 (Model RJTENS-1) sends gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin to relieve pain. The device has 16 programs (12 standard programs and 4 editable programs). It is a battery-powered portable device, comprising electronic stimulatory module and accessories of lead wires, electrodes and 4x1.5V AAA alkaline batteries. Two outlet sockets are used to connect skin electrodes by lead wires. The accessories of electrodes is 510(k) cleared device (K213879), Size 50*50mm.
The provided text describes the 510(k) summary for the Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1). Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are implicitly derived from its substantial equivalence to the predicate device (K202893). The "Comparison" column in the table indicates "Same" or "Similar" for most parameters, meaning the new device's performance aligns with the established performance of the predicate. Note 1 explicitly addresses the difference in deviation from amplitude, frequency, and pulse width.
| Parameter | Acceptance Criteria (Predicate Device K202893) | Reported Device Performance (Model RJTENS-1) |
|---|---|---|
| Indications for Use | Same as predicate | Same as predicate |
| Type of Use | Prescription use | Prescription use |
| Power Source(s) | 1.5Vx4 AAA alkaline battery | 1.5Vx4 AAA alkaline battery |
| Method of Line Current Isolation | N/A | N/A |
| Patient Leakage Current - Normal Condition | 2μΑ | 2μΑ |
| Patient Leakage Current - Single Fault Condition | NA | NA |
| Average DC current through electrodes |
§ 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).