(203 days)
Transcutaneous Electrical Nerve Stimulation (TENS) devices are used for the symptomatic relief and management of chronic (long-term) intractable pain and as an adjunctive treatment in the management of post-surgical and post-taumatic acute pain problems.
(TENS) Transcutaneous Electrical Nerve Stimulator For Pain Relief - Class II Model BMLS02-4
The provided text is a 510(k) clearance letter from the FDA for a medical device called the "Electro-Nerve Stimulator TENS Model BMLS02-4." This type of document primarily confirms that a new device is substantially equivalent to a predicate device already on the market, meaning it has the same intended use and technological characteristics as a legally marketed device, or has different characteristics but does not raise new questions of safety and effectiveness.
Such a letter typically does not contain detailed information about the acceptance criteria or a study that proves the device meets specific performance criteria in the way you might find in an efficacy or clinical trial report. The 510(k) pathway focuses on substantial equivalence rather than explicit proof of efficacy against specific objective benchmarks.
Therefore,Based on the provided text, I cannot extract the information required to populate your requested table and answer your specific questions about acceptance criteria and performance studies. The document is a 510(k) clearance letter, which attests to substantial equivalence with a predicate device, but does not detail performance acceptance criteria or the specific studies that prove the device meets them.
The document states:
- Device Name: Electro-Nerve Stimulator TENS Model BMLS02-4
- Regulation Name: Transcutaneous electrical nerve stimulator for pain relief.
- Indications for Use: Transcutaneous Electrical Nerve Stimulation (TENS) devices are used for the symptomatic relief and management of chronic (long-term) intractable pain and as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain problems.
To get the information you asked for (acceptance criteria table, sample size, expert qualifications, etc.), you would typically need to refer to the original 510(k) submission summary or a separate clinical study report, neither of which is present or referenced in detail in this FDA clearance letter.
§ 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).