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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 K895183
Device Name REBOX II (TENS)
Applicant
Rebox (Uk) , Ltd.
Intl. Sq.
1825 Eye St., NW Suite 400
Washington,  DC  20006
Applicant Contact RICHARD T NEY
Correspondent
Rebox (Uk) , Ltd.
Intl. Sq.
1825 Eye St., NW Suite 400
Washington,  DC  20006
Correspondent Contact RICHARD T NEY
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received08/11/1989
Decision Date 01/19/1990
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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