Normatec Elite
K-Number: K240122 · 2024-03-21
ApplicantNormaTec Industries, LP
Decision Date2024-03-21
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent
Device Summary
Normatec Elite is a medical device manufactured by NormaTec Industries, LP. It received FDA 510(k) clearance on 2024-03-21 under approval number K240122. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Normatec Elite?
Normatec Elite is a medical device that received FDA 510(k) clearance on 2024-03-21. It is manufactured by NormaTec Industries, LP. The 510(k) number is K240122.
When was Normatec Elite approved by the FDA?
Normatec Elite received FDA 510(k) clearance on 2024-03-21, under approval number K240122.
What company makes Normatec Elite?
Normatec Elite is manufactured by NormaTec Industries, LP.
What is the FDA product code for Normatec Elite?
The FDA product code for Normatec Elite is IRP.
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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.