Navigator (FMNVG15); Navigator XL (FMNVX06)
K-Number: K240105 · 2024-08-29
ApplicantForcemech International, LLC
Decision Date2024-08-29
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
Navigator (FMNVG15); Navigator XL (FMNVX06) is a medical device manufactured by Forcemech International, LLC. It received FDA 510(k) clearance on 2024-08-29 under approval number K240105. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Navigator (FMNVG15); Navigator XL (FMNVX06)?
Navigator (FMNVG15); Navigator XL (FMNVX06) is a medical device that received FDA 510(k) clearance on 2024-08-29. It is manufactured by Forcemech International, LLC. The 510(k) number is K240105.
When was Navigator (FMNVG15); Navigator XL (FMNVX06) approved by the FDA?
Navigator (FMNVG15); Navigator XL (FMNVX06) received FDA 510(k) clearance on 2024-08-29, under approval number K240105.
What company makes Navigator (FMNVG15); Navigator XL (FMNVX06)?
Navigator (FMNVG15); Navigator XL (FMNVX06) is manufactured by Forcemech International, LLC.
What is the FDA product code for Navigator (FMNVG15); Navigator XL (FMNVX06)?
The FDA product code for Navigator (FMNVG15); Navigator XL (FMNVX06) is ITI.
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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.