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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered
510(k) Number K871421
Device Name MODEL HL-100 PORTABLE DC ELECT. THERAPEUTIC UNIT
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 Number890.5850
Classification Product Code
IPF  
Date Received04/09/1987
Decision Date 01/22/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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