ManaFlexx 2 (model: MF002-RX, MF002-OTC)
K-Number: K231569 · 2023-11-03
ApplicantManamed, Inc.
Decision Date2023-11-03
Product CodeNUH
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
ManaFlexx 2 (model: MF002-RX, MF002-OTC) is a medical device manufactured by Manamed, Inc.. It received FDA 510(k) clearance on 2023-11-03 under approval number K231569. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ManaFlexx 2 (model: MF002-RX, MF002-OTC)?
ManaFlexx 2 (model: MF002-RX, MF002-OTC) is a medical device that received FDA 510(k) clearance on 2023-11-03. It is manufactured by Manamed, Inc.. The 510(k) number is K231569.
When was ManaFlexx 2 (model: MF002-RX, MF002-OTC) approved by the FDA?
ManaFlexx 2 (model: MF002-RX, MF002-OTC) received FDA 510(k) clearance on 2023-11-03, under approval number K231569.
What company makes ManaFlexx 2 (model: MF002-RX, MF002-OTC)?
ManaFlexx 2 (model: MF002-RX, MF002-OTC) is manufactured by Manamed, Inc..
What is the FDA product code for ManaFlexx 2 (model: MF002-RX, MF002-OTC)?
The FDA product code for ManaFlexx 2 (model: MF002-RX, MF002-OTC) is NUH.
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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.