Cleared Traditional

K220289 - FridaMom Anti-Nausea Bands (FDA 510(k) Clearance)

K220289 · Fridababy, LLC · Neurology device
Jun 2022
Decision
148d
Days
-
Risk

K220289 is an FDA 510(k) clearance for the FridaMom Anti-Nausea Bands. This device is classified as a Device, Acupressure.

Submitted by Fridababy, LLC (Miami, US). The FDA issued a Cleared decision on June 29, 2022, 148 days after receiving the submission on February 1, 2022.

This device falls under the Neurology FDA review panel.

Submission Details

510(k) Number K220289 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2022
Decision Date June 29, 2022
Days to Decision 148 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code MVV - Device, Acupressure
Device Class -