ManaSport
K-Number: K210284 · 2022-04-26
ApplicantManamed, Inc.
Decision Date2022-04-26
Product CodeIMI
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
ManaSport is a medical device manufactured by Manamed, Inc.. It received FDA 510(k) clearance on 2022-04-26 under approval number K210284. The device is classified under product code IMI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ManaSport?
ManaSport is a medical device that received FDA 510(k) clearance on 2022-04-26. It is manufactured by Manamed, Inc.. The 510(k) number is K210284.
When was ManaSport approved by the FDA?
ManaSport received FDA 510(k) clearance on 2022-04-26, under approval number K210284.
What company makes ManaSport?
ManaSport is manufactured by Manamed, Inc..
What is the FDA product code for ManaSport?
The FDA product code for ManaSport is IMI.
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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.