TeleRehab Aermos Cardiopulmonary Rehabilitation
FDA 510(k) K250259 · The ScottCare Corporation
510(k) numberK250259
Submission
- Device name
- TeleRehab Aermos Cardiopulmonary Rehabilitation
- Applicant
- The ScottCare Corporation
Cleveland, OH, US - Received
- January 28, 2025
- Decision date
- June 4, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRG – Transmitters And Receivers, Physiological Signal, Radiofrequency
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2910
- Specialty
- Cardiovascular
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Questions and answers
When was TeleRehab Aermos Cardiopulmonary Rehabilitation cleared by the FDA?
TeleRehab Aermos Cardiopulmonary Rehabilitation (K250259) received a 510(k) decision of Substantially Equivalent on June 4, 2025, 127 days after the submission was received.
What is the product code of K250259?
The FDA product code is DRG – Transmitters And Receivers, Physiological Signal, Radiofrequency, a Class II (moderate risk) device regulated under 21 CFR 870.2910.