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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bed, Patient Rotation, Powered
510(k) Number K933964
Device Name THE CRADLE
Applicant
The Primal Energy Research Foundation
2222 Westerland
Suite 1
Houston,  TX  77063
Applicant Contact LEWIS A MANSON
Correspondent
The Primal Energy Research Foundation
2222 Westerland
Suite 1
Houston,  TX  77063
Correspondent Contact LEWIS A MANSON
Regulation Number890.5225
Classification Product Code
IKZ  
Date Received08/16/1993
Decision Date 10/03/1994
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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