K141168 - ANSISTIM (FDA 510(k) Clearance)

K141168 is an FDA 510(k) clearance for the ANSISTIM. Classified as Stimulator, Electro-acupuncture (product code BWK).

Submitted by Dyansys, Inc. (San Mateo, US). The FDA issued a Cleared decision on May 15, 2015 after a review of 374 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

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