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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 K840882
Device Name HOME CARE WATER FLOTATION BED HC4/TC/H
Applicant
Western Medical, Ltd.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Western Medical, Ltd.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.5170
Classification Product Code
IOQ  
Date Received02/27/1984
Decision Date 07/18/1984
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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