Cleared Traditional

Wearable Breast Pump (Model S9)

K220596 · Shenzhen TPH Technology Co., Ltd. · Obstetrics & Gynecology
May 2022
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K220596 is an FDA 510(k) clearance for the Wearable Breast Pump (Model S9), 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 May 26, 2022, 86 days after receiving the submission on March 1, 2022. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5160.

Submission Details

510(k) Number K220596 FDA.gov
FDA Decision Cleared SESE
Date Received March 01, 2022
Decision Date May 26, 2022
Days to Decision 86 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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