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 a medical device manufactured by Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2025-08-01 under approval 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. It is manufactured by Ge Medical Systems, LLC. The 510(k) number is K250941.
When was Revolution Vibe approved by the FDA?
Revolution Vibe received FDA 510(k) clearance on 2025-08-01, under approval number K250941.
What company makes Revolution Vibe?
Revolution Vibe is manufactured by Ge Medical Systems, LLC.
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.