K-number	K211460
Device name	Air Relax Plus Model AR-3.0
Applicant	Diode Art Engineering Doing Business AS Air Relax
Product code	IRP
Device class	Class II
Decision date	May 25, 2021
Decision	Substantially Equivalent
Regulation	890.5650

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Source

View the full FDA submission: accessdata.fda.gov

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Air Relax Plus Model AR-3.0

Everything you need for a 510(k) submission. Nothing you don't.