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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 K952680
Device Name VARAPULSE-2
Applicant
Staodyne, Inc.
1225 Florida Ave.
P.O. Box 1379
Longmont,  CO  80502
Applicant Contact JAMES W MORGAN
Correspondent
Staodyne, Inc.
1225 Florida Ave.
P.O. Box 1379
Longmont,  CO  80502
Correspondent Contact JAMES W MORGAN
Regulation Number890.5850
Classification Product Code
IPF  
Date Received06/12/1995
Decision Date 12/04/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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