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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, muscle, powered, for muscle conditioning
510(k) Number K191181
Device Name NXPRO Neuromuscular Electrical Stimulation Device
Applicant
NeuX Technologies, Inc.
3802 Spectrum Blvd. Suite 112F
Tampa,  FL  33612
Applicant Contact Scot Minniear
Correspondent
Devine Guidance International, Inc.
4730 South Fort Apache Road, Suite 300
Las Vegas,  NV  89147
Correspondent Contact Christopher J. Devine
Regulation Number890.5850
Classification Product Code
NGX  
Date Received05/02/2019
Decision Date 10/11/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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