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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K261522
Device Name BioWave BioWraps
Applicant
Biowave Corporation
19 Newtown Tpke.
Westport,  CT  06880
Applicant Contact Bradford Siff
Correspondent
MCRA, an IQVIA Business
803 7th St. NW
4th Floor
Washington,  DC  20001
Correspondent Contact Emily Andre
Regulation Number882.1320
Classification Product Code
GXY  
Date Received05/07/2026
Decision Date 06/03/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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