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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K822224
Device Name EMPI SINGLE USE
Applicant
Empi
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Empi
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number882.1320
Classification Product Code
GXY  
Date Received07/27/1982
Decision Date 08/16/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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