(293 days)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities.
Not Found
The provided text is a U.S. FDA 510(k) clearance letter for the "Mini TENS Therapy Device Model JPD-ES100". This document is a regulatory communication stating that the device is substantially equivalent to legally marketed predicate devices. It does not contain details about acceptance criteria, device performance study results, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/medical imaging device.
The 510(k) clearance process for a TENS device typically relies on demonstrating substantial equivalence to pre-existing devices by showing it meets recognized standards for electrical safety and performance, rather than clinical efficacy studies with the kind of details requested in your prompt (e.g., expert reads, ground truth, MRMC studies) which are more common for novel diagnostic or AI-powered devices.
Therefore, I cannot extract the information requested in your prompt from the provided document. The 510(k) letter primarily focuses on the regulatory clearance and general controls applicable to the device.
§ 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).