(246 days)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, back, arm, leg, foot, due to strain from exercise or normal household and work activities.
Transcutaneous Electrical Nerve Stimulator is a product that adopts modern electronic science and technology to deliver electric pulses generated to the user's skin through the electrodes.
There are three models of Transcutaneous Electrical Nerve Stimulator which are KTR-206, KTR-208 and KTR-209. Their technical parameters are slightly different, but they share the basically same characteristics: 1) They are small, exquisite and portable; 2) various modes to satisfy different demands, applicable to a wider range of people; 3) wonderful electric pulse combination. 0~16 levels can be adjusted and chosen according to personal preference; 4) LCD display make the operation simple and easy; 5) integrated design of the body is easy for function operation and simple in practical use; 6) battery power display; 7) dual channel output. user can cover more treatment areas. For KTR-208 and KTR-209, the two channels are independently controlled for intensity adjustment which is more convenient to use.
The Transcutaneous Electrical Nerve Stimulator is mainly composed of the host and electrode patches. And it uses AAA batteries for power supply. To start therapy, first insert batteries, then paste the electrode patches onto painful areas and press on/off button to power on. The modes and intensity can be selected according to needs. And the current status is displayed on LCD.
The provided text is a 510(k) Summary for a Transcutaneous Electrical Nerve Stimulator (TENS) device. This document is a premarket submission to the FDA demonstrating that the new device is substantially equivalent to a legally marketed predicate device.
Here's an analysis of the provided text, addressing your specific questions, keeping in mind that a 510(k) typically focuses on substantial equivalence rather than a full clinical trial to establish new clinical efficacy. Therefore, some information, like detailed acceptance criteria from a clinical study or human reader performance, may not be explicitly present as they aren't usually required for a 510(k) for this type of device.
1. Table of Acceptance Criteria and the Reported Device Performance
For a TENS device, acceptance criteria in a 510(k) submission primarily revolve around safety, electrical performance, and substantial equivalence to a predicate device, rather than clinical efficacy metrics (like pain reduction improvement percentage). The document establishes "substantial equivalence" as the primary acceptance criterion.
The table below summarizes the comparison to the predicate device, which serves as the de-facto performance standard for substantial equivalence. The "Acceptance Criteria" are implied by the predicate values and compliance with recognized standards.
| Item | Acceptance Criteria (Implied by Predicate/Standards) | Reported Device Performance (Targeted Device) | Outcome |
|---|---|---|---|
| Regulatory Information | |||
| Regulation number | 21 CFR 882.5890 | 21 CFR 882.5890 | Same |
| Regulation description | Transcutaneous electrical nerve stimulator for pain relief | Transcutaneous electrical nerve stimulator for pain relief | Same |
| Product code | NUH | NUH | Same |
| Class | II | II | Same |
| Indications for Use | Temporary relief of pain associated with sore or aching muscles | Temporary relief of pain associated with sore and aching muscles in the shoulder, back, arm, leg, foot, due to strain from exercise or normal household and work activities. | Similar |
| Patient population | Adult | Adult | Same |
| Location for use | OTC | OTC | Same |
| Basic Unit Specifications | |||
| Leakage current | Compliant with IEC 60601-2-10 (Battery operated: N/A) | N/A (Battery operated) | Same |
| Software/Firmware/Microprocessor Control? | Yes | Yes | Same |
| Automatic Overload trip | Yes (Predicate: Yes) | No (Predicate: Yes) | Different |
| Automatic no-load trip | Yes | Yes | Same |
| Patient override control method | On/Off button | On/Off button | Similar |
| Indicator display -On/Off status | Yes | Yes | Same |
| Indicator display -Low battery | Yes | Yes | Same |
| Automatic Shut Off | Yes | Yes | Same |
| Housing material and construction | ABS | ABS | Same |
| Compliance with voluntary standards | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-11 | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-11 | Similar |
| Compliance with 21CFR 898 | Yes | Yes | Same |
| Output Specifications | |||
| Waveform | Biphasic, Pulsed symmetric, square wave (Predicate is various) | Biphasic, Pulsed symmetric, square wave | Similar |
| Net Charge (per pulse) | 0 | 0 | Same |
| Maximum Average Current ($500\Omega$) |
§ 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).