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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bed, Flotation Therapy, Powered
510(k) Number K970636
Device Name TOTALCARE., MODULAR THERAPY SYSTEM (MTS)
Applicant
Hill-Rom, Inc.
1069 State Rte. 46 E.
Batesville,  IN  47006
Applicant Contact JAMES G CARPENTER
Correspondent
Hill-Rom, Inc.
1069 State Rte. 46 E.
Batesville,  IN  47006
Correspondent Contact JAMES G CARPENTER
Regulation Number890.5170
Classification Product Code
IOQ  
Date Received02/20/1997
Decision Date 08/26/1997
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
Recalls CDRH Recalls
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