Normatec Elite
K-Number: K240122 · 2024-03-21
Device Summary
Frequently Asked Questions
What is the Normatec Elite?
Normatec Elite is a medical device that received FDA 510(k) clearance on 2024-03-21. The listed applicant is NormaTec Industries, LP. The 510(k) number is K240122.
When did Normatec Elite receive FDA 510(k) clearance?
Normatec Elite received FDA 510(k) clearance on 2024-03-21, under 510(k) number K240122.
Who is the listed applicant for Normatec Elite?
The FDA 510(k) record lists NormaTec Industries, LP as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Normatec Elite?
The FDA product code for Normatec Elite is IRP.
Other records listing NormaTec Industries, LP 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: IRP)
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.