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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered
510(k) Number K800068
Device Name ELECTRICAL MUSCLE STIMULATOR (EMS)
Applicant
Staodynamics, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Staodynamics, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number890.5850
Classification Product Code
IPF  
Date Received01/11/1980
Decision Date 02/05/1980
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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