FDA applicant

9th Wave, Inc.

Mt Pleasant, SC3 decisions1996–19970 recalls

FDA records 3 decisions for 9th Wave, Inc. (Mt Pleasant, SC) from 1996 to 1997: 3 510(k) clearances. All are in product code FNM (Mattress, Air Flotation, Alternating Pressure). 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 9th Wave, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for 9th Wave, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — 9th Wave, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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9th Wave, Inc.

Which product codes does it file in?

What has FDA decided for it lately?