PEGASUS BIWAVE PLUS SYSTEM— 510(k) K944310

Name: FDA 510(k) clearance K944310
Creator: U.S. Food and Drug Administration
Published: 1995-03-17

Substantially Equivalent

Pegasus Airwave, Inc.

FDA 510(k) clearance K944310 for PEGASUS BIWAVE PLUS SYSTEM, Substantially Equivalent on 1995-03-17. Applicant: Pegasus Airwave, Inc.. Device class: 2.

Clearance details

Applicant: Pegasus Airwave, Inc.
Product code: Code FNM
Device class: Class 2
Regulation: 21 CFR 880.5550
Advisory panel: General Hospital
Date received: 1994-09-02
Decision date: 1995-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deerfield Beach, FL, US

Download summary PDF View on FDA.gov ↗

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K930742 — PEGASUS PROACTIVE WHEELCHAIR CUSHION1994-03-31
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Adverse events under product code FNM

product code FNM

Death: 22
Injury: 349
Other: 4
Total: 375

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.