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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 K010295
Device Name MICROSTIM 100I TENS DEVICE
Applicant
MICROSTIM, INC.
7881 N.W. 90TH AVE.
TAMARAC,  FL  33321
Applicant Contact JOEL ROSSEN
Correspondent
MICROSTIM, INC.
7881 N.W. 90TH AVE.
TAMARAC,  FL  33321
Correspondent Contact JOEL ROSSEN
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received01/31/2001
Decision Date 08/03/2001
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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