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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Physical Therapy, Multi Function
510(k) Number K862411
Device Name THE RELAXARE EXERCISE AND MASSAGE UNIT
Applicant
Relaxare Corp.
8900 Eton Ave.
Canoga Park,  CA  91304
Applicant Contact BRENDA ANDERSON
Correspondent
Relaxare Corp.
8900 Eton Ave.
Canoga Park,  CA  91304
Correspondent Contact BRENDA ANDERSON
Regulation Number890.5880
Classification Product Code
JFB  
Date Received06/25/1986
Decision Date 07/09/1986
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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