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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Acupressure
510(k) Number K220289
Device Name FridaMom Anti-Nausea Bands
Applicant
Fridababy, LLC
82 NE 26th St. Suite 101
Miami,  FL  33137
Applicant Contact Jeffrey Davidson
Correspondent
I-Squared Group, LLC
111 Ohlinger Rd.
Shoemakersville,  PA  19555
Correspondent Contact Angela F. Lassandro
Classification Product Code
MVV  
Date Received02/01/2022
Decision Date 06/29/2022
Decision Substantially Equivalent (SESE)
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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