ManaFlexx 2 (model: MF002-RX, MF002-OTC)
K-Number: K231569 · 2023-11-03
Device Summary
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. The listed applicant is Manamed, Inc.. The 510(k) number is K231569.
When did ManaFlexx 2 (model: MF002-RX, MF002-OTC) receive FDA 510(k) clearance?
ManaFlexx 2 (model: MF002-RX, MF002-OTC) received FDA 510(k) clearance on 2023-11-03, under 510(k) number K231569.
Who is the listed applicant for ManaFlexx 2 (model: MF002-RX, MF002-OTC)?
The FDA 510(k) record lists Manamed, Inc. as the applicant. This does not by itself establish the device manufacturer.
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.
Other records listing Manamed, Inc. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: NUH)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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.