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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interactive Rehabilitation Exercise Devices
510(k) Number K880631
Device Name 2K-QDA MOTION/GAIT ANALYSIS SYSTEM
Applicant
Human Performance Technologies, Inc.
12 Technology Dr., Suite 6
East Setauket,  NY  11733
Applicant Contact MICHAEL E WITOVER
Correspondent
Human Performance Technologies, Inc.
12 Technology Dr., Suite 6
East Setauket,  NY  11733
Correspondent Contact MICHAEL E WITOVER
Regulation Number890.5360
Classification Product Code
LXJ  
Date Received02/16/1988
Decision Date 04/21/1988
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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