Air Relax Pro Model AR-4.0— 510(k) K212491

Substantially Equivalent

Diode Art Engineering Doing Business AS Air Relax

FDA 510(k) clearance K212491 for Air Relax Pro Model AR-4.0, Substantially Equivalent on 2021-09-02. Applicant: Diode Art Engineering Doing Business AS Air Relax. Device class: 2.

Clearance details

Applicant
Diode Art Engineering Doing Business AS Air Relax
Product code
Code IRP
Device class
Class 2
Regulation
21 CFR 890.5650
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Pico Rivera, CA, US
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