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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Exerciser, Powered
510(k) Number K852065
Device Name PRESTON LOWER LIMB CPM UNIT
Applicant
Therapeutic Equipment Corp.
60 Page Rd.
Clifton,  NJ  07012
Applicant Contact ALAN P SCHWARTZ
Correspondent
Therapeutic Equipment Corp.
60 Page Rd.
Clifton,  NJ  07012
Correspondent Contact ALAN P SCHWARTZ
Regulation Number890.5380
Classification Product Code
BXB  
Date Received05/13/1985
Decision Date 07/19/1985
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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