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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 K860847
Device Name WALLANT NEUROLOGIX GENERAL PURPOSE TENS
Applicant
WALLANT INTL. TRADE, INC.
312 - 314 COX ST.
ROSELLE,  NJ  07203
Applicant Contact ELMER ARLUCK
Correspondent
WALLANT INTL. TRADE, INC.
312 - 314 COX ST.
ROSELLE,  NJ  07203
Correspondent Contact ELMER ARLUCK
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received03/06/1986
Decision Date 08/07/1986
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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