K250259 is an FDA 510(k) clearance for the TeleRehab Aermos Cardiopulmonary Rehabilitation. This device is classified as a Transmitters And Receivers, Physiological Signal, Radiofrequency (Class II - Special Controls, product code DRG).
Submitted by The ScottCare Corporation (Cleveland, US). The FDA issued a Cleared decision on June 4, 2025, 127 days after receiving the submission on January 28, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2910.
| 510(k) Number | K250259 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 28, 2025 |
| Decision Date | June 04, 2025 |
| Days to Decision | 127 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DRG - Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2910 |