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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 K811012
Device Name TENS-O-MATIC
Applicant
O-Matic, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
O-Matic, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received04/15/1981
Decision Date 06/01/1981
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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