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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 K011543
Device Name TENS CARE, MODEL XL-Y3
Applicant
TENS CARE LTD.
76, STOCKPORT ROAD
TIMPERLRY,  GB WA15 7SN
Applicant Contact BERNARD JOHN TREMAINE
Correspondent
TENS CARE LTD.
76, STOCKPORT ROAD
TIMPERLRY,  GB WA15 7SN
Correspondent Contact BERNARD JOHN TREMAINE
Regulation Number882.5890
Classification Product Code
GZJ  
Subsequent Product Code
IPF  
Date Received05/18/2001
Decision Date 08/31/2001
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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