Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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 Road
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
-
-