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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 K841382
Device Name EMPI MODEL 712, LOGIX, NMS
Applicant
Empi
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Empi
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number890.5850
Classification Product Code
IPF  
Date Received04/02/1984
Decision Date 05/07/1984
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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