Cleared Traditional

Needle Stimulator (Model: RJNS6-1)

K220153 · Bozhou Rongjian Medical Appliance Co., Ltd. · Neurology

Mar 2022

Decision

58d

Days

—

Risk

About This 510(k) Submission

K220153 is an FDA 510(k) clearance for the Needle Stimulator (Model: RJNS6-1), a Stimulator, Electro-acupuncture, submitted by Bozhou Rongjian Medical Appliance Co., Ltd. (Bozhou, CN). The FDA issued a Cleared decision on March 18, 2022, 58 days after receiving the submission on January 19, 2022. This device falls under the Neurology review panel.

Submission Details

510(k) Number	K220153 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 19, 2022
Decision Date	March 18, 2022
Days to Decision	58 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF