Portable Mesh Nebulizer

Nebulizer (direct Patient Interface)

FeelLife Health Inc.

The following data is part of a premarket notification filed by Feellife Health Inc. with the FDA for Portable Mesh Nebulizer.

Pre-market Notification Details

Device IDK182906
510k NumberK182906
Device Name:Portable Mesh Nebulizer
ClassificationNebulizer (direct Patient Interface)
Applicant FeelLife Health Inc. Room 1903, Building A, No.9 Furong Road, Tantou Bao'an District Shenzhen,  CN 518104
ContactOwen Zhang
CorrespondentJonathan Hu
Medwheat (Shanghai) Medical Technology Co. Ltd. Yangpu District Liaoyuan East Road Shuangyang First Suite No. 33 Room 303 Shanghai,  CN 200082
Product CodeCAF  
CFR Regulation Number868.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-10-17
Decision Date2020-09-27

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