The following data is part of a premarket notification filed by Fridababy Llc with the FDA for Fridamom Anti-nausea Bands.
Device ID | K220289 |
510k Number | K220289 |
Device Name: | FridaMom Anti-Nausea Bands |
Classification | Device, Acupressure |
Applicant | FridaBaby LLC 82 NE 26th St Suite 101 Miami, FL 33137 |
Contact | Jeffrey Davidson |
Correspondent | Angela F. Lassandro I-Squared Group, LLC 111 Ohlinger Road Shoemakersville, PA 19555 |
Product Code | MVV |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-02-01 |
Decision Date | 2022-06-29 |