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 a medical device manufactured by Diode Art Engineering Doing Business AS Air Relax. It received FDA 510(k) clearance on 2021-09-02 under approval 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. It is manufactured by Diode Art Engineering Doing Business AS Air Relax. The 510(k) number is K212491.
When was Air Relax Pro Model AR-4.0 approved by the FDA?
Air Relax Pro Model AR-4.0 received FDA 510(k) clearance on 2021-09-02, under approval number K212491.
What company makes Air Relax Pro Model AR-4.0?
Air Relax Pro Model AR-4.0 is manufactured by Diode Art Engineering Doing Business AS Air Relax.
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 Devices by Diode Art Engineering Doing Business AS Air Relax
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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.