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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, for muscle conditioning
510(k) Number K134001
Device Name FIREFLY
Applicant
FIRSTKIND LIMITED
231 FAIRBANKS STREET
WEST BOYLSTON,  MA  01583
Applicant Contact SHEILA HEMEON-HEYER
Correspondent
FIRSTKIND LIMITED
231 FAIRBANKS STREET
WEST BOYLSTON,  MA  01583
Correspondent Contact SHEILA HEMEON-HEYER
Regulation Number890.5850
Classification Product Code
NGX  
Date Received12/27/2013
Decision Date 05/15/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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