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FDA 510(k)

Revolution Vibe

K-Number: K250941 · 2025-08-01

ApplicantGe Medical Systems, LLC
Decision Date2025-08-01
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Revolution Vibe is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2025-08-01 under 510(k) number K250941. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Revolution Vibe?

Revolution Vibe is a medical device that received FDA 510(k) clearance on 2025-08-01. The listed applicant is Ge Medical Systems, LLC. The 510(k) number is K250941.

When did Revolution Vibe receive FDA 510(k) clearance?

Revolution Vibe received FDA 510(k) clearance on 2025-08-01, under 510(k) number K250941.

Who is the listed applicant for Revolution Vibe?

The FDA 510(k) record lists Ge Medical Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Revolution Vibe?

The FDA product code for Revolution Vibe is JAK.

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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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