Cleared Traditional

Wearable Breast Pump (Model S1DW)

K222045 · Shenzhen TPH Technology Co., Ltd. · Obstetrics & Gynecology
Jan 2023
Decision
177d
Days
Class 2
Risk

About This 510(k) Submission

K222045 is an FDA 510(k) clearance for the Wearable Breast Pump (Model S1DW), a Pump, Breast, Powered (Class II — Special Controls, product code HGX), submitted by Shenzhen TPH Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on January 4, 2023, 177 days after receiving the submission on July 11, 2022. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5160.

Submission Details

510(k) Number K222045 FDA.gov
FDA Decision Cleared SESE
Date Received July 11, 2022
Decision Date January 04, 2023
Days to Decision 177 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code HGX — Pump, Breast, Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.5160

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