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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 K864114
Device Name TENS DEVICE FOR RELIEF OF CHRONIC PAIN
Applicant
Futuremed Div. of Future Impex Corp.
2076 Deer Park Ave.
Deerpark,  NY  11729
Applicant Contact MORAD DAVOUDZADEH
Correspondent
Futuremed Div. of Future Impex Corp.
2076 Deer Park Ave.
Deerpark,  NY  11729
Correspondent Contact MORAD DAVOUDZADEH
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received10/21/1986
Decision Date 04/01/1987
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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