Air Relax Pro Model AR-4.0

Massager, Powered Inflatable Tube

Diode Art Engineering Doing Business As Air Relax

The following data is part of a premarket notification filed by Diode Art Engineering Doing Business As Air Relax with the FDA for Air Relax Pro Model Ar-4.0.

Pre-market Notification Details

Device IDK212491
510k NumberK212491
Device Name:Air Relax Pro Model AR-4.0
ClassificationMassager, Powered Inflatable Tube
Applicant Diode Art Engineering Doing Business As Air Relax 9535 Brasher St Pico Rivera,  CA  90660
ContactBeomjoon Lee
CorrespondentPrithul Bom
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeIRP  
CFR Regulation Number890.5650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2021-08-09
Decision Date2021-09-02

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