Cleared Traditional

TeleRehab Aermos Cardiopulmonary Rehabilitation

K250259 · The ScottCare Corporation · Cardiovascular

Jun 2025

Decision

127d

Days

Class 2

Risk

About This 510(k) Submission

K250259 is an FDA 510(k) clearance for the TeleRehab Aermos Cardiopulmonary Rehabilitation, 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 review panel. Regulated under 21 CFR 870.2910.

Submission Details

510(k) Number	K250259 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	DRG — Transmitters And Receivers, Physiological Signal, Radiofrequency
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.2910