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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 K201131
Device Name firefly T-2
Firstkind Limited
Hawk House, Peregrine Business Park
High Wycombe,  GB HP13 7DL
Applicant Contact Neil Buckley
Heyer Regulatory Solutions LLC
125 Cherry Lane
Amherst,  MA  01002
Correspondent Contact Sheila Hemeon-Heyer
Regulation Number890.5850
Classification Product Code
Date Received04/28/2020
Decision Date 05/28/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No