510(k) Report

FDA applicant

Rehabilitation Institute,Loma Linda University Med

Chicago, IL1 decision2003–20030 recalls

FDA records 1 decision for Rehabilitation Institute,Loma Linda University Med (Chicago, IL) in 2003: 1 510(k) clearance. All are in product code MVA (Orthosis, Cranial). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Rehabilitation Institute,Loma Linda University Med’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Rehabilitation Institute,Loma Linda University Med since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Rehabilitation Institute,Loma Linda University Med by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MVAOrthosis, Cranial1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K023572Loma Linda University Medical Center (Llumc) Cranial Remolding HelmetRehabilitation Institute,Loma Linda University Med · 20031cites it

What has FDA decided for it lately?

  • K023572Loma Linda University Medical Center (Llumc) Cranial Remolding HelmetRehabilitation Institute,Loma Linda University Med · 2003

The one decision as Rehabilitation Institute,Loma Linda University Med →

Other applicant names beginning “Rehabilitation”

FDA records each applicant name separately; these may or may not be the same firm.

Rehabilitation Technologies Division 1