Cleared Traditional

K223238 - STARband 3D
(FDA 510(k) Clearance)

K223238 · Orthomerica Products, Inc. · Neurology
Apr 2023
Decision
182d
Days
Class 2
Risk

K223238 is an FDA 510(k) clearance for the STARband 3D, a Orthosis, Cranial (Class II — Special Controls, product code MVA), submitted by Orthomerica Products, Inc. (Orlando, US). The FDA issued a Cleared decision on April 20, 2023, 182 days after receiving the submission on October 20, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5970.

Submission Details

510(k) Number K223238 FDA.gov
FDA Decision Cleared SESE
Date Received October 20, 2022
Decision Date April 20, 2023
Days to Decision 182 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code MVA — Orthosis, Cranial
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5970