(269 days)
Transcutaneous Electronic Nerve Stimulator is indicated for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
Transcutaneous Electronic Nerve Stimulator (Models: KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2491, KTR-2492, KTR-2493, KTR-2494) is a portable and battery powered multifunctional device, offering Transcutaneous Electronic Nerve Stimulator. They can give certain electrical pulse through electrode pads placed on the skin to help users to enjoy body stimulation.
For models: KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2301, KTR-2302, KTR-2342 have 3 operation modes:
For models: KTR-2491, KTR-2493, KTR-2493, KTR-2494 have 15 operation modes, 9 manual mode, and 6 automatic mode. They can be remotely controlled with an accessory remote control. And there is a LCD displays on remote control, which display mode and treatment time.
The electronic stimulator module has unified the operating elements of ON/OFF button. Intensity adjust button and Mode selection button.
The device is equipped with accessories of electrode pads, batteries and remote control (For KTR-249X series).
The electrode pads are complying with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization), are interchangeable.
The provided text describes a 510(k) premarket notification for a Transcutaneous Electronic Nerve Stimulator (TENS) and does not contain information about acceptance criteria and a study proving the device meets those criteria, as typically understood in the context of diagnostic or prognostic AI/ML medical devices.
Instead, this document is a regulatory submission demonstrating substantial equivalence to previously cleared predicate devices. The "Test Summary" and "Comparison to predicate device" sections outline engineering tests and comparisons of technical specifications, rather than clinical performance studies against specific acceptance criteria for diagnostic accuracy.
Therefore, an output table as requested cannot be fully populated. However, I can extract the relevant information regarding the tests performed to support the "substantial equivalence" claim.
Here's a breakdown of what is available:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission for a TENS device, the "acceptance criteria" are related to industrial standards and engineering specifications rather than diagnostic performance metrics (e.g., sensitivity, specificity, AUC) typically seen with AI/ML devices. The reported "performance" is compliance with these standards and comparison of technical specifications to predicate devices.
| Acceptance Criterion (Standard/Parameter) | Reported Device Performance (Compliance/Value) |
|---|---|
| Electrical safety | Complies with IEC 60601-1, IEC 60601-1-11, IEC 60601-2-10 |
| Electromagnetic compatibility (EMC) | Complies with IEC 60601-1-2 |
| Biocompatibility | Complies with ISO 10993-1, ISO 10993-5, ISO 10993-10 (for electrode pads) |
| Usability | Complies with IEC 62366-1 |
| Software verification and validation | Complies with FDA "Guidance for Pre-Market Submissions and for Software Contained in Medical Devices" |
| Waveform output specifications | Verified by waveform test report according to FDA guidance for TENS and Powered Muscle Stimulator |
| Patient Leakage Current (NC DC) | 0.5µA (Matches predicate) |
| Patient Leakage Current (SFC DC) | 0.6μΑ (Matches predicate) |
| Average DC current through electrodes (device on, no pulses) |
§ 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).