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FDA 510(k)

Normatec 3

K-Number: K220217 · 2022-02-25

Decision Date2022-02-25
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Normatec 3 is the device name listed in this FDA 510(k) record. The listed applicant is NormaTec Industries, LP. It received FDA 510(k) clearance on 2022-02-25 under 510(k) number K220217. 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 3?

Normatec 3 is a medical device that received FDA 510(k) clearance on 2022-02-25. The listed applicant is NormaTec Industries, LP. The 510(k) number is K220217.

When did Normatec 3 receive FDA 510(k) clearance?

Normatec 3 received FDA 510(k) clearance on 2022-02-25, under 510(k) number K220217.

Who is the listed applicant for Normatec 3?

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 3?

The FDA product code for Normatec 3 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.

View all 8 devices →

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.