AXUS ES-5 Electro-Acupuncture Device

Stimulator, Electro-acupuncture

Lhasa OMS, INC.

The following data is part of a premarket notification filed by Lhasa Oms, Inc. with the FDA for Axus Es-5 Electro-acupuncture Device.

Pre-market Notification Details

Device IDK200636
510k NumberK200636
Device Name:AXUS ES-5 Electro-Acupuncture Device
ClassificationStimulator, Electro-acupuncture
Applicant Lhasa OMS, INC. 230 Libbey Parkway Weymouth,  MA  02189
ContactColleen Pike
CorrespondentSaori Sawaki
Ken Block Consulting, LLC 800 E. Campbell Road, Suite 202 Richardson,  TX  75081
Product CodeBWK  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-10
Decision Date2021-02-03

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