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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810028771697 | K220289 | 000 |