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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Therapeutic, Electric
510(k) Number K904242
Device Name QI-GONG MACHINE THERAPEUTIC MASSAGER
Applicant
China Healthways Institute
155 Del Mar
San Clemente,  CA  92672
Applicant Contact RICHARD LEE
Correspondent
China Healthways Institute
155 Del Mar
San Clemente,  CA  92672
Correspondent Contact RICHARD LEE
Regulation Number890.5660
Classification Product Code
ISA  
Date Received09/17/1990
Decision Date 10/11/1990
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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