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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 K212762
Device Name geko W-2
Applicant
Firstkind Limited
Hawk House
Peregrine Business Park
High Wycombe,  GB HP137DL
Applicant Contact Neil Buckley
Correspondent
Heyer Regulatory Solutions, LLC
125 Cherry Ln.
Amherst,  MA  01002
Correspondent Contact Sheila Hemeon-Heyer
Regulation Number890.5850
Classification Product Code
IPF  
Date Received08/31/2021
Decision Date 11/29/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Clinical Trials NCT02482038
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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