FDA applicant

Ergo-Air, Inc.

Westbury, NY3 decisions1995–19950 recalls

FDA records 3 decisions for Ergo-Air, Inc. (Westbury, NY) in 1995: 3 510(k) clearances. Most are in product codes FNM (Mattress, Air Flotation, Alternating Pressure) and MOC (Cushion, Flotation, Therapeutic). 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, general hospital panel, where it files most

How often FDA has decided Ergo-Air, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ergo-Air, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ergo-Air, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ergo-Air, 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 “Ergo-Air”

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

Ergo Intl., Ent., Inc. 5 Ergo Instruments, Inc. 1 Ergo-Flex Technologies, LLC 1

Ergo-Air, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Ergo-Air”