(217 days)
- Specific indications: it is used for the symptomatic relief and management of chronic, intractable pain and as an adjunctive treatment in the management of post surgical and post traumatic acute pain problems.
- Clinical settings: should be used under the instruction or prescriptions by . qualified health professionals prior to the applications of the device at home or hospital facilities.
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This document is a 510(k) premarket notification clearance letter from the FDA for a Transcutaneous Electrical Nerve Stimulator (TENS) device. It does not contain information about a study proving the device meets acceptance criteria, an AI algorithm's performance, or any of the detailed metrics requested in your prompt.
Specifically, the document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."
Substantial equivalence (SE) is the primary pathway for 510(k) clearance. It means the new device is as safe and effective as a legally marketed predicate device. This process typically involves demonstrating that the new device has the same intended use and technological characteristics as the predicate, or if there are different technological characteristics, that they do not raise different questions of safety and effectiveness and that the device is as safe and effective as the predicate.
Therefore, I cannot provide the requested information as it is not present in the provided text.
§ 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).