TeleRehab Aermos Cardiopulmonary Rehabilitation— 510(k) K250259

Substantially Equivalent

The ScottCare Corporation

FDA 510(k) clearance K250259 for TeleRehab Aermos Cardiopulmonary Rehabilitation, Substantially Equivalent on 2025-06-04. Applicant: The ScottCare Corporation.

Clearance details

Applicant: The ScottCare Corporation
Product code: Code DRG
Advisory panel: Cardiovascular
Date received: 2025-01-28
Decision date: 2025-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRG

product code DRG

Death: 5
Total: 5

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.