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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 K913522
Device Name SOLITENS MODIFIED
Applicant
Innovative Designer Products, Inc.
175 Rock Rd.
Glen Rock,  NJ  07452
Applicant Contact SAUL LISS
Correspondent
Innovative Designer Products, Inc.
175 Rock Rd.
Glen Rock,  NJ  07452
Correspondent Contact SAUL LISS
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received07/26/1991
Decision Date 08/28/1991
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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