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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, Manual
510(k) Number K912512
Device Name TAICHI STICK MASSAGER
Applicant
Focus International, Inc.
416 Hungerford Dr., Suite 204
Rockville,  MD  20850
Applicant Contact RONY LAI
Correspondent
Focus International, Inc.
416 Hungerford Dr., Suite 204
Rockville,  MD  20850
Correspondent Contact RONY LAI
Regulation Number890.5660
Classification Product Code
LYG  
Date Received06/06/1991
Decision Date 09/06/1991
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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