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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 K182440
Device Name Body System
Applicant
A-1 Engineering
30 Mauchly Suite A
Irvine,  CA  92618
Applicant Contact Tony Picciano
Correspondent
Sage BioPartners
1741 Little Kate Dr
Park City,  UT  84060
Correspondent Contact Peter Knauer
Regulation Number890.5850
Classification Product Code
NGX  
Date Received09/07/2018
Decision Date 02/26/2019
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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