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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Transcutaneous, For Pain Relief
510(k) Number K831147
Device Name OMNIPROBE ELECTRICAL NERVE STIMULATOR
Applicant
Omni Intl., Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Omni Intl., Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received04/08/1983
Decision Date 07/18/1983
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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