Cleared Traditional

Needle Stimulator

K202861 · Wuxi Jiajian Medical Instrument Co., Ltd. · Neurology
Aug 2021
Decision
333d
Days
—
Risk

About This 510(k) Submission

K202861 is an FDA 510(k) clearance for the Needle Stimulator, a Stimulator, Electro-acupuncture, submitted by Wuxi Jiajian Medical Instrument Co., Ltd. (Wuxi, CN). The FDA issued a Cleared decision on August 27, 2021, 333 days after receiving the submission on September 28, 2020. This device falls under the Neurology review panel.

Submission Details

510(k) Number K202861 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 2020
Decision Date August 27, 2021
Days to Decision 333 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

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