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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, Lesion, Radiofrequency
510(k) Number K220122
Device Name APEX 6
Applicant
Rf Innovations, Inc.
30 Log Bridge Rd.
Middleton,  MA  01949
Applicant Contact William Rittman
Correspondent
Kamm & Associates
8870 Ravello Ct.
Naples,  FL  34114
Correspondent Contact Daniel Kamm
Regulation Number882.4400
Classification Product Code
GXD  
Date Received01/18/2022
Decision Date 03/15/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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