P-STIM SYSTEM (K050123) - FDA 510(k) Clearance

K050123 is an FDA 510(k) clearance for the P-STIM SYSTEM. Classified as Stimulator, Electro-acupuncture (product code BWK).

Submitted by Neuroscience Therapy Corp. (Kirkland, US). The FDA issued a Cleared decision on March 30, 2006 after a review of 435 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Neuroscience Therapy Corp. devices