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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 K093999
Device Name ARP POV SPORT
Applicant
ARP MANUFACTURING, INC
4655 KIRKWOOD COURT
boulder,  CO  80301
Applicant Contact lewis ward
Correspondent
ARP MANUFACTURING, INC
4655 KIRKWOOD COURT
boulder,  CO  80301
Correspondent Contact lewis ward
Regulation Number890.5850
Classification Product Code
NGX  
Date Received12/28/2009
Decision Date 08/10/2010
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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