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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 K922690
Device Name PAIN-EEZ
Applicant
International Center For Nutritional Research
40 Ct. St.
Newtown,  PA  18940
Applicant Contact GERALD H SMITH
Correspondent
International Center For Nutritional Research
40 Ct. St.
Newtown,  PA  18940
Correspondent Contact GERALD H SMITH
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received06/04/1992
Decision Date 10/13/1992
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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