9TH WAVE MODELS 500 & 550 LOW AIR LOSS SYSTEMS— 510(k) K963620

Name: FDA 510(k) clearance K963620
Creator: U.S. Food and Drug Administration
Published: 1997-01-07

Substantially Equivalent

9th Wave, Inc.

FDA 510(k) clearance K963620 for 9TH WAVE MODELS 500 & 550 LOW AIR LOSS SYSTEMS, Substantially Equivalent on 1997-01-07. Applicant: 9th Wave, Inc.. Device class: 2.

Clearance details

Applicant: 9th Wave, Inc.
Product code: Code FNM
Device class: Class 2
Regulation: 21 CFR 880.5550
Advisory panel: General Hospital
Date received: 1996-09-10
Decision date: 1997-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mt Pleasant, SC, US

Download summary PDF View on FDA.gov ↗

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K973169 — PRESSURE GUARD SITE SELECT (A)1998-02-20
K972022 — ZAK-20001998-01-22
K974319 — MIGHTY AIR1998-01-22
K974070 — PHYSIO/10001998-01-06
K972549 — SIMPULSE1997-11-18

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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.