Cleared Traditional

K220289 - FridaMom Anti-Nausea Bands

K220289 · Fridababy, LLC · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2022
Decision
148d
Days
-
Risk

K220289 is an FDA 510(k) clearance for the FridaMom Anti-Nausea Bands. Classified as Device, Acupressure (product code MVV).

Submitted by Fridababy, LLC (Miami, US). The FDA issued a Cleared decision on June 29, 2022 after a review of 148 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Fridababy, LLC devices

FDA 510(k) Submission Details - K220289

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 148d · This submission: 148d
Pathway characteristics
Predicate-based equivalence.

MVV Device Classification - Class 0,

Product Code MVV Device, Acupressure
Device Class -

Regulatory Consultant

I-Squared Group, LLC
Angela F. Lassandro

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.