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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
510(k) Number K073361
Device Name MUSCLE PAIN DEVICE (MPD)
Applicant
Stevens Proof of Concept, Inc.
68 Southfield Ave. Suite 100-2
Stamford Landing
Stamford,  CT  06902
Applicant Contact JECKIN D SHAH
Correspondent
Underwriters Laboratories, Inc.
12 Laboratory Dr.
Research Triangel Park,  NC  27709
Correspondent Contact JEFF D RONGERO
Regulation Number890.5850
Classification Product Code
IPF  
Date Received11/30/2007
Decision Date 03/18/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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