FLEXICAIR LOW AIRLOSS THERAPY UNIT— 510(k) K920382

Substantially Equivalent

Support Systems Intl.

FDA 510(k) clearance K920382 for FLEXICAIR LOW AIRLOSS THERAPY UNIT, Substantially Equivalent on 1992-04-07. Applicant: Support Systems Intl..

Clearance details

Applicant: Support Systems Intl.
Product code: Code IOQ
Advisory panel: Physical Medicine
Date received: 1992-01-30
Decision date: 1992-04-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

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Adverse events under product code IOQ

product code IOQ

Malfunction: 676
Other: 5
Total: 681

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.