510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K250259Substantially Equivalent

TeleRehab Aermos Cardiopulmonary Rehabilitation

Scottcare Corporation, Cleveland OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K250259 is the FDA 510(k) clearance record for TeleRehab Aermos Cardiopulmonary Rehabilitation, a class II device, cleared for The ScottCare Corporation on under FDA product code DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency). FDA records list 7 510(k) clearances for The ScottCare Corporation, from to . As of , FDA records show no recalls naming K250259.

Clearance record

Decision date
Received
(127 days to decision)
Product code
DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Regulation
21 CFR 870.2910
Device class
Class II
Review panel
Cardiovascular
Applicant
The ScottCare Corporation 4791 W. 150th St., Cleveland OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DRG

Trailing 12 months
2 clearances under product code DRG in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DRG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260