Air Relax Plus Model AR-3.0

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 Plus Model Ar-3.0.

Pre-market Notification Details

Device IDK211460
510k NumberK211460
Device Name:Air Relax Plus Model AR-3.0
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 Received2021-05-11
Decision Date2021-05-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08809040526400 K211460 000
08809040526288 K211460 000
08809040526295 K211460 000
08809040526301 K211460 000
08809040526318 K211460 000
08809040526325 K211460 000
08809040526332 K211460 000
08809040526349 K211460 000
08809040526356 K211460 000
08809040526363 K211460 000
08809040526370 K211460 000
08809040526387 K211460 000
08809040526394 K211460 000
08809040526271 K211460 000

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