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FDA 510(k)

TeleRehab Aermos Cardiopulmonary Rehabilitation

K-Number: K250259 · 2025-06-04

ApplicantThe ScottCare Corporation
Decision Date2025-06-04
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TeleRehab Aermos Cardiopulmonary Rehabilitation is the device name listed in this FDA 510(k) record. The listed applicant is The ScottCare Corporation. It received FDA 510(k) clearance on 2025-06-04 under 510(k) number K250259. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TeleRehab Aermos Cardiopulmonary Rehabilitation?

TeleRehab Aermos Cardiopulmonary Rehabilitation is a medical device that received FDA 510(k) clearance on 2025-06-04. The listed applicant is The ScottCare Corporation. The 510(k) number is K250259.

When did TeleRehab Aermos Cardiopulmonary Rehabilitation receive FDA 510(k) clearance?

TeleRehab Aermos Cardiopulmonary Rehabilitation received FDA 510(k) clearance on 2025-06-04, under 510(k) number K250259.

Who is the listed applicant for TeleRehab Aermos Cardiopulmonary Rehabilitation?

The FDA 510(k) record lists The ScottCare Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TeleRehab Aermos Cardiopulmonary Rehabilitation?

The FDA product code for TeleRehab Aermos Cardiopulmonary Rehabilitation is DRG.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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