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FDA 510(k)

Medicalgorithmics Unified Cardiac Rehabilitation System

K-Number: K173969 · 2018-07-11

ApplicantMedicalgorithmics S.A.
Decision Date2018-07-11
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Medicalgorithmics Unified Cardiac Rehabilitation System is a medical device manufactured by Medicalgorithmics S.A.. It received FDA 510(k) clearance on 2018-07-11 under approval number K173969. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medicalgorithmics Unified Cardiac Rehabilitation System?

Medicalgorithmics Unified Cardiac Rehabilitation System is a medical device that received FDA 510(k) clearance on 2018-07-11. It is manufactured by Medicalgorithmics S.A.. The 510(k) number is K173969.

When was Medicalgorithmics Unified Cardiac Rehabilitation System approved by the FDA?

Medicalgorithmics Unified Cardiac Rehabilitation System received FDA 510(k) clearance on 2018-07-11, under approval number K173969.

What company makes Medicalgorithmics Unified Cardiac Rehabilitation System?

Medicalgorithmics Unified Cardiac Rehabilitation System is manufactured by Medicalgorithmics S.A..

What is the FDA product code for Medicalgorithmics Unified Cardiac Rehabilitation System?

The FDA product code for Medicalgorithmics Unified Cardiac Rehabilitation System is DSI.

Related Clinical Trials

NCT06727942 Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes RECRUITING NCT07613762 High-Flow Nasal Cannula on Exercise Tolerance in Heart Failure Patients Undergoing Cardiac Rehabilitation. NOT_YET_RECRUITING NCT03280862 DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS COMPLETED NCT03053791 Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait RECRUITING NCT07616050 Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients NOT_YET_RECRUITING NCT04097145 Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial RECRUITING

Related PubMed Literature

PMID: 36632328 Integrating real-world data to assess cardiac ablation device outcomes in a multicenter study using the OMOP common data model for regulatory decisions: implementation and evaluation. JAMIA open (2023)

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Official Source

View on FDA Database →

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

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