Class Class II
TeleRehab Aermos Cardiopulmonary Rehabilitation (K250259)
Description
TeleRehab Aermos Cardiopulmonary Rehabilitation by The ScottCare Corporation, an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250259
Clearance Date2025-06-04
Clearance TypeTraditional
Product CodeDRG
Regulation Number870.2910
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250259
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. TeleRehab Aermos Cardiopulmonary Rehabilitation (K250259) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K212883 | ers2 - ergoline Rehabilitation System | Ergoline GmbH | 2022 |
| K161056 | Telemetry Transmitter | Edan Instruments, Inc. | 2017 |
Trace the full predicate network for K250259
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.