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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
510(k) Number K894152
Device Name MEDITHERM
Applicant
Medical Equipment Designs, Inc.
601 E. Broadway
Suite 203-A
Jefferson City,  TN  37760
Applicant Contact BARTON HAGGARD
Correspondent
Medical Equipment Designs, Inc.
601 E. Broadway
Suite 203-A
Jefferson City,  TN  37760
Correspondent Contact BARTON HAGGARD
Regulation Number890.5300
Classification Product Code
IMI  
Date Received06/14/1989
Decision Date 06/11/1990
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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