SWELL-RELIEF— 510(k) K855004

Substantially Equivalent

D.A. Schulman, Inc.

FDA 510(k) clearance K855004 for SWELL-RELIEF, Substantially Equivalent on 1986-02-12. Applicant: D.A. Schulman, Inc..

Clearance details

Applicant: D.A. Schulman, Inc.
Product code: Code DRM
Advisory panel: Cardiovascular
Date received: 1985-12-13
Decision date: 1986-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brooklyn Park, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRM

product code DRM

Death: 82
Injury: 126
Malfunction: 4,539
Total: 4,747

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.