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FDA 510(k)

TCL3 Motion Tracking System

K-Number: K221785 · 2022-08-29

ApplicantTracinnovations A/S
Decision Date2022-08-29
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TCL3 Motion Tracking System is a medical device manufactured by Tracinnovations A/S. It received FDA 510(k) clearance on 2022-08-29 under approval number K221785. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TCL3 Motion Tracking System?

TCL3 Motion Tracking System is a medical device that received FDA 510(k) clearance on 2022-08-29. It is manufactured by Tracinnovations A/S. The 510(k) number is K221785.

When was TCL3 Motion Tracking System approved by the FDA?

TCL3 Motion Tracking System received FDA 510(k) clearance on 2022-08-29, under approval number K221785.

What company makes TCL3 Motion Tracking System?

TCL3 Motion Tracking System is manufactured by Tracinnovations A/S.

What is the FDA product code for TCL3 Motion Tracking System?

The FDA product code for TCL3 Motion Tracking System is LNH.

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Related PubMed Literature

PMID: 39670276 Multicenter Evaluation of Machine-Learning Continuous Pulse Rate Algorithm on Wrist-Worn Device. Digital biomarkers (2024)

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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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