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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 K010615
Device Name CYCLOTEC AMT CTI TENS DEVICE
Applicant
Cyclotec
4871 Northwest 65th Ave.
Lauderhill,  FL  33319
Applicant Contact STEPHEN A MICHELSON
Correspondent
Cyclotec
4871 Northwest 65th Ave.
Lauderhill,  FL  33319
Correspondent Contact STEPHEN A MICHELSON
Regulation Number882.5890
Classification Product Code
GZJ  
Subsequent Product Code
GXY  
Date Received03/01/2001
Decision Date 10/12/2001
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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