Cleared Traditional

AXUS ES-5 Electro-Acupuncture Device

K200636 · Lhasa Oms, Inc. · Neurology

Feb 2021

Decision

330d

Days

—

Risk

About This 510(k) Submission

K200636 is an FDA 510(k) clearance for the AXUS ES-5 Electro-Acupuncture Device, a Stimulator, Electro-acupuncture, submitted by Lhasa Oms, Inc. (Weymouth, US). The FDA issued a Cleared decision on February 3, 2021, 330 days after receiving the submission on March 10, 2020. This device falls under the Neurology review panel.

Submission Details

510(k) Number	K200636 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 10, 2020
Decision Date	February 03, 2021
Days to Decision	330 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF