Cleared Traditional

JIAJIAN ELECTRO-ACUPUNCTURE STIMULATORS

K122812 · Wuxi Jiajian Medical Instrument Co., Ltd. · Neurology
Apr 2013
Decision
210d
Days
—
Risk

About This 510(k) Submission

K122812 is an FDA 510(k) clearance for the JIAJIAN ELECTRO-ACUPUNCTURE STIMULATORS, a Stimulator, Electro-acupuncture, submitted by Wuxi Jiajian Medical Instrument Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on April 11, 2013, 210 days after receiving the submission on September 13, 2012. This device falls under the Neurology review panel.

Submission Details

510(k) Number K122812 FDA.gov
FDA Decision Cleared SESE
Date Received September 13, 2012
Decision Date April 11, 2013
Days to Decision 210 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

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

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