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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Physiological Signal, Radiofrequency
510(k) Number K250259
Device Name TeleRehab Aermos Cardiopulmonary Rehabilitation
Applicant
The ScottCare Corporation
4791 W 150th St.
Cleveland,  OH  44135
Applicant Contact Matthew Tarler
Correspondent
The ScottCare Corporation
4791 W 150th St.
Cleveland,  OH  44135
Correspondent Contact Matthew Tarler
Regulation Number870.2910
Classification Product Code
DRG  
Subsequent Product Codes
DRT   MWI  
Date Received01/28/2025
Decision Date 06/04/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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