Cleared Traditional

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

K220289 · Fridababy, LLC · Neurology device
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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

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
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.

Device Classification

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.