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FDA 510(k)

HeroTracker Sense

K-Number: K250022 · 2025-06-30

ApplicantVoluntis
Decision Date2025-06-30
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HeroTracker Sense is a medical device manufactured by Voluntis. It received FDA 510(k) clearance on 2025-06-30 under approval number K250022. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HeroTracker Sense?

HeroTracker Sense is a medical device that received FDA 510(k) clearance on 2025-06-30. It is manufactured by Voluntis. The 510(k) number is K250022.

When was HeroTracker Sense approved by the FDA?

HeroTracker Sense received FDA 510(k) clearance on 2025-06-30, under approval number K250022.

What company makes HeroTracker Sense?

HeroTracker Sense is manufactured by Voluntis.

What is the FDA product code for HeroTracker Sense?

The FDA product code for HeroTracker Sense is CAF.

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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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