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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 K933237
Device Name MEDI-STIM, MODIFICATION
Applicant
Mid-Canada Medical
5630 Tomken Rd.
Mississauga, Ontario,  CA L4W 1P4
Applicant Contact JANE BELROSE
Correspondent
Mid-Canada Medical
5630 Tomken Rd.
Mississauga, Ontario,  CA L4W 1P4
Correspondent Contact JANE BELROSE
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received06/24/1993
Decision Date 09/08/1994
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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