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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 K020846
Device Name ULTIMA TENS XL-A1
Applicant
Tenscare, Ltd.
76 Stockport Rd.
Timperley, Cheshire,  GB WA15 7SN
Applicant Contact BERNARD J TREMAINE
Correspondent
Tenscare, Ltd.
76 Stockport Rd.
Timperley, Cheshire,  GB WA15 7SN
Correspondent Contact BERNARD J TREMAINE
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received03/15/2002
Decision Date 05/21/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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