K241781

Substantially Equivalent

Solo Pace Control

Applicant: Solo Pace, Inc.
Product code: DTE
Advisory panel: Cardiovascular
Date received: 2024-06-20
Decision date: 2025-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Petaluma, CA, US

Adverse events under product code DTE

product code DTE

Death: 18
Injury: 247
Malfunction: 4,603
Total: 4,868

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.