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510(k) K250259

TeleRehab Aermos Cardiopulmonary Rehabilitation by The ScottCare Corporation — Product Code DRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 2025
Date Received
January 28, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
Device Class
Class II
Regulation Number
870.2910
Review Panel
CV
Submission Type

Other clearances by The ScottCare Corporation

  • K142180 — TELESENSE (December 12, 2014)
  • K092947 — TELESENTRY, MODEL TS01 (February 26, 2010)
  • K083382 — CHROMA, MODEL: RZ153C (August 13, 2009)
  • K081359 — GENESIS ECP (May 29, 2008)

Other clearances for product code DRG

  • K252984 — Perin Health System (PHD80060-2) (January 22, 2026)
  • K252440 — EasyTeleMed (2.0.2) (October 2, 2025)
  • K243837 — iBSM (May 16, 2025)
  • K242018 — UbiqVue™ 2A Multi-parameter System (UX2550) (November 12, 2024)
  • K241101 — BioButton System (September 26, 2024)
  • K240251 — ANNE Chest (June 3, 2024)
  • K223711 — ANNE One (August 10, 2023)
  • K220526 — HD+12, HD+15 (May 15, 2023)
  • K223073 — Alio (March 17, 2023)
  • K222398 — Care Team Portal (February 6, 2023)