AIRHYTHM HEALTHCARE BED— 510(k) K935837

Substantially Equivalent

Healthcare Designs

FDA 510(k) clearance K935837 for AIRHYTHM HEALTHCARE BED, Substantially Equivalent on 1994-06-21. Applicant: Healthcare Designs.

Clearance details

Applicant: Healthcare Designs
Product code: Code FNL
Advisory panel: General Hospital
Date received: 1993-12-07
Decision date: 1994-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Saginaw, TX, US

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Adverse events under product code FNL

product code FNL

Death: 64
Injury: 728
Malfunction: 10,825
Other: 9
Total: 11,626

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.