Cleared Traditional

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

Aug 2013
Decision
149d
Days
-
Risk

K130768 is an FDA 510(k) clearance for the JIAJIAN CMN STIMULATOR. This device is classified as a Stimulator, Electro-acupuncture.

Submitted by Wuxi Jiajian Medical Instrument Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on August 16, 2013, 149 days after receiving the submission on March 20, 2013.

This device falls under the Neurology FDA review panel.

Submission Details

510(k) Number K130768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2013
Decision Date August 16, 2013
Days to Decision 149 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code BWK - Stimulator, Electro-acupuncture
Device Class -