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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electromagnetic stimulator, pain relief
510(k) Number K210021
Device Name Axon Therapy
NeuraLace Medical, Inc.
3770 Tansy St #101
San Diego,  CA  92121
Applicant Contact Joe Milkovits
AcKnowledge Regulatory Strategies LLC
2251 San Diego Ave, Suite B-257
San Diego,  CA  92121
Correspondent Contact Allison C. Komiyama
Regulation Number882.5890
Classification Product Code
Subsequent Product Code
Date Received01/04/2021
Decision Date 06/11/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No