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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-10-17
Decision Date2020-09-27

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06934325388540 K182906 000
06934325302249 K182906 000
06934325302263 K182906 000
06934325301846 K182906 000
06934325319490 K182906 000
06934325322278 K182906 000
06934325338705 K182906 000
06934325349237 K182906 000
06934325358475 K182906 000
06934325371733 K182906 000
06934325376950 K182906 000
06934325380353 K182906 000
00848530099497 K182906 000

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