Cleared Traditional

MyCRO Band

K201426 · Otto Bock Healthcare LP · Neurology
Mar 2021
Decision
301d
Days
Class 2
Risk

About This 510(k) Submission

K201426 is an FDA 510(k) clearance for the MyCRO Band, a Orthosis, Cranial (Class II — Special Controls, product code MVA), submitted by Otto Bock Healthcare LP (Salt Lake City, US). The FDA issued a Cleared decision on March 26, 2021, 301 days after receiving the submission on May 29, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5970.

Submission Details

510(k) Number K201426 FDA.gov
FDA Decision Cleared SESE
Date Received May 29, 2020
Decision Date March 26, 2021
Days to Decision 301 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