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The XLTEK NeuroPath is intended to stimulate and measure neuromuscular signals that are useful in diagnosing and evaluating systemic and entrapment neuropathies.

The XLTEK NeuroPath is intended to be used as an adjunct to and not a replacement for conventional electrodiagnostic measurements.

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The provided text is a 510(k) clearance letter from the FDA for the XLTEK NeuroPath device. This type of document primarily confirms that a new medical device is "substantially equivalent" to an already legally marketed predicate device.

Crucially, a 510(k) clearance letter itself does NOT typically contain detailed information about specific acceptance criteria or the comprehensive results of performance studies that prove a device meets those criteria.

Instead, the manufacturer (Excel-Tech Ltd. in this case) would have submitted detailed performance data, acceptance criteria, and study protocols to the FDA as part of their 510(k) submission. The FDA reviews this information to make their substantial equivalence determination.

Therefore, based solely on the provided text, I cannot provide the requested information. The text confirms the device name, K-number, regulation number, regulatory class, and its intended use, but it does not delve into the specifics of performance studies or acceptance criteria.

To answer your questions, one would need access to the actual 510(k) submission (traditional or special, which contain more detailed information), which is often publicly available through the FDA's Dockets Management Staff or a Freedom of Information Act (FOIA) request, though summaries are typically available on the FDA's 510(k) database.

In summary, the provided document is an FDA clearance letter, not the study report itself.

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