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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Exerciser, Measuring
510(k) Number K870872
Device Name DISCIPLINE I
Applicant
Physio Systems, Inc.
4450 Enterprise St. Suite 101
Fremont,  CA  94538
Applicant Contact ANDREW A WADE
Correspondent
Physio Systems, Inc.
4450 Enterprise St. Suite 101
Fremont,  CA  94538
Correspondent Contact ANDREW A WADE
Regulation Number890.5360
Classification Product Code
ISD  
Date Received03/03/1987
Decision Date 03/23/1987
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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