K122812 - JIAJIAN ELECTRO-ACUPUNCTURE STIMULATORS (FDA 510(k) Clearance)

K122812 is an FDA 510(k) clearance for the JIAJIAN ELECTRO-ACUPUNCTURE STIMULATORS. 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 April 11, 2013 after a review of 210 days - an extended review cycle.

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.

View all Wuxi Jiajian Medical Instrument Co., Ltd. devices