Wearable Breast Pump (Model S9)

Pump, Breast, Powered

Shenzhen TPH Technology Co., Ltd.

The following data is part of a premarket notification filed by Shenzhen Tph Technology Co., Ltd. with the FDA for Wearable Breast Pump (model S9).

Pre-market Notification Details

Device IDK220596
510k NumberK220596
Device Name:Wearable Breast Pump (Model S9)
ClassificationPump, Breast, Powered
Applicant Shenzhen TPH Technology Co., Ltd. 5th Floor, Lianchuang 2nd Technology Park, Bulan Road, Nanwan Community, Longgang District Shenzhen,  CN 518100
ContactPeter Chen
CorrespondentPeter Chen
Shenzhen TPH Technology Co., Ltd. 5th Floor, Lianchuang 2nd Technology Park, Bulan Road, Nanwan Community, Longgang District Shenzhen,  CN 518100
Product CodeHGX  
CFR Regulation Number884.5160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-01
Decision Date2022-05-26

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