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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, for pain relief
510(k) Number K032928
Device Name MEDIPHYSICS PAIN TREATMENT SYSTEM, MODEL 1
Applicant
MEDIPHYSICS PAIN CENTERS OF AMERICA
13 ORCHARD ROAD
UNIT 108
LAKE FOREST,  CA  92630
Applicant Contact JAMES ROGERS
Correspondent
UNDERWRITERS LABORATORIES, INC.
1655 SCOTT BLVD.
SANTA CLARA,  CA  95050
Correspondent Contact MORTEN SIMON CHRISTENSEN
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received09/22/2003
Decision Date 12/19/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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