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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 K940600
Device Name STIMULATOR, NERVE, TRANSCUTANEOUS, (PAIN RELIEF) 84-GZJ
Applicant
Progressive Concepts, Inc.
22194 Hillsboro Rd.
Denton,  MD  21629
Applicant Contact RAY FISCHER
Correspondent
Progressive Concepts, Inc.
22194 Hillsboro Rd.
Denton,  MD  21629
Correspondent Contact RAY FISCHER
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received02/10/1994
Decision Date 09/29/1995
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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