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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Powered
510(k) Number K993443
Device Name RTD ARM ASSISTIVE ROBOTIC DEVICE
Applicant
Rehabilitation Technologies Division
1275 Bloomfield Ave.
Fairfield,  NJ  07004
Applicant Contact RICHARD M MAHONEY
Correspondent
Rehabilitation Technologies Division
1275 Bloomfield Ave.
Fairfield,  NJ  07004
Correspondent Contact RICHARD M MAHONEY
Regulation Number890.3860
Classification Product Code
ITI  
Date Received10/12/1999
Decision Date 12/17/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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