K130768 - JIAJIAN CMN STIMULATOR (FDA 510(k) Clearance)

K130768 is an FDA 510(k) clearance for the JIAJIAN CMN STIMULATOR. Classified as Stimulator, Electro-acupuncture (product code BWK).

Submitted by Wuxi Jiajian Medical Instrument Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on August 16, 2013 after a review of 149 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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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