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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 K980958
Device Name HAKOMED ELECDT/VACUPULLS
Applicant
Alive, Inc.
537 Cummins St.
Honolulu,  HI  96814
Applicant Contact KAI HANSJURGENS
Correspondent
Alive, Inc.
537 Cummins St.
Honolulu,  HI  96814
Correspondent Contact KAI HANSJURGENS
Regulation Number890.5850
Classification Product Code
IPF  
Subsequent Product Code
LIH  
Date Received03/16/1998
Decision Date 05/11/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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