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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 K821523
Device Name OMNI TENS
Applicant
OMNI INTL., INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
OMNI INTL., INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received05/21/1982
Decision Date 06/16/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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