AUTOPULSE, MODEL 100— 510(k) K011046

Substantially Equivalent

Revivant Corp.

FDA 510(k) clearance K011046 for AUTOPULSE, MODEL 100, Substantially Equivalent on 2001-10-25. Applicant: Revivant Corp..

Clearance details

Applicant: Revivant Corp.
Product code: Code DRM
Advisory panel: Cardiovascular
Date received: 2001-04-06
Decision date: 2001-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, 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.