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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Powered Inflatable Tube
510(k) Number K821920
Device Name I.C.E. BOX
Applicant
Lhs Industries
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Lhs Industries
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.5650
Classification Product Code
IRP  
Date Received06/28/1982
Decision Date 08/31/1982
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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