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FDA 510(k)

Air Relax Pro Model AR-4.0

K-Number: K212491 · 2021-09-02

Decision Date2021-09-02
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Air Relax Pro Model AR-4.0 is the device name listed in this FDA 510(k) record. The listed applicant is Diode Art Engineering Doing Business AS Air Relax. It received FDA 510(k) clearance on 2021-09-02 under 510(k) number K212491. 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 Air Relax Pro Model AR-4.0?

Air Relax Pro Model AR-4.0 is a medical device that received FDA 510(k) clearance on 2021-09-02. The listed applicant is Diode Art Engineering Doing Business AS Air Relax. The 510(k) number is K212491.

When did Air Relax Pro Model AR-4.0 receive FDA 510(k) clearance?

Air Relax Pro Model AR-4.0 received FDA 510(k) clearance on 2021-09-02, under 510(k) number K212491.

Who is the listed applicant for Air Relax Pro Model AR-4.0?

The FDA 510(k) record lists Diode Art Engineering Doing Business AS Air Relax as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Air Relax Pro Model AR-4.0?

The FDA product code for Air Relax Pro Model AR-4.0 is IRP.

Other records listing Diode Art Engineering Doing Business AS Air Relax 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

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