FDA applicant

Reflexion Health, Inc.

San Diego, CA3 decisions2015–20190 recalls

FDA records 3 decisions for Reflexion Health, Inc. (San Diego, CA) from 2015 to 2019: 3 510(k) clearances. All are in product code LXJ (Interactive Rehabilitation Exercise Devices). 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, physical medicine panel, where it files most

How often FDA has decided Reflexion Health, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2019

2015high 2 (2019) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Reflexion Health, Inc. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Reflexion Health, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Reflexion”

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

Reflexion Medical, Inc. 3

Reflexion Health, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Reflexion”