HeroTracker Sense
K-Number: K250022 · 2025-06-30
Device Summary
Frequently Asked Questions
What is the HeroTracker Sense?
HeroTracker Sense is a medical device that received FDA 510(k) clearance on 2025-06-30. The listed applicant is Voluntis. The 510(k) number is K250022.
When did HeroTracker Sense receive FDA 510(k) clearance?
HeroTracker Sense received FDA 510(k) clearance on 2025-06-30, under 510(k) number K250022.
Who is the listed applicant for HeroTracker Sense?
The FDA 510(k) record lists Voluntis as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for HeroTracker Sense?
The FDA product code for HeroTracker Sense is CAF.
Other records listing Voluntis as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: CAF)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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.