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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, nerve, transcutaneous, over-the-counter
510(k) Number K231569
Device Name ManaFlexx 2 (model: MF002-RX, MF002-OTC)
Applicant
ManaMed, Inc
5240 W. Charleston Blvd
Suite 150
Las Vegas,  NV  89146
Applicant Contact Trevor Theriot
Correspondent
Guangzhou GLOMED Biological Technology Co., Ltd.
2231, Building 1, Rui Feng Center, Kaichuang Road
Huangpu District
Guangzhou,  CN 510000
Correspondent Contact Cassie Lee
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Codes
GZJ   IPF   NGX   NYN  
Date Received05/31/2023
Decision Date 11/03/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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