COMFORTADE— 510(k) K926435

Substantially Equivalent

Sensible Products

FDA 510(k) clearance K926435 for COMFORTADE, Substantially Equivalent on 1993-08-19. Applicant: Sensible Products.

Clearance details

Applicant: Sensible Products
Product code: Code FNL
Advisory panel: General Hospital
Date received: 1992-12-23
Decision date: 1993-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Barbara, CA, US

Download summary PDF View on FDA.gov ↗

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.