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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. STE 101
FREMONT,  CA  94538
Applicant Contact ANDREW A WADE
Correspondent
PHYSIO SYSTEMS, INC.
4450 ENTERPRISE ST. STE 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
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