FDA 510(k)

Re:Balans

K-Number: K243727 · 2025-10-16

Decision Date2025-10-16

Product CodeDSB

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Re:Balans is the device name listed in this FDA 510(k) record. The listed applicant is Mode Sensors AS. It received FDA 510(k) clearance on 2025-10-16 under 510(k) number K243727. The device is classified under product code DSB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Re:Balans?

Re:Balans is a medical device that received FDA 510(k) clearance on 2025-10-16. The listed applicant is Mode Sensors AS. The 510(k) number is K243727.

When did Re:Balans receive FDA 510(k) clearance?

Re:Balans received FDA 510(k) clearance on 2025-10-16, under 510(k) number K243727.

Who is the listed applicant for Re:Balans?

The FDA 510(k) record lists Mode Sensors AS as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Re:Balans?

The FDA product code for Re:Balans is DSB.

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Official Source

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