BED ROCKING DEVICE— 510(k) K801517

Substantially Equivalent

Wesler

FDA 510(k) clearance K801517 for BED ROCKING DEVICE, Substantially Equivalent on 1980-10-10. Applicant: Wesler.

Clearance details

Applicant: Wesler
Product code: Code FNJ
Advisory panel: General Hospital
Date received: 1980-07-01
Decision date: 1980-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FNJ

product code FNJ

Death: 6
Total: 6

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.