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Wearable breast pump (model S12A)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K243508

by Shenzhen TPH Technology Co., Ltd

Identifiers

510(k) Number
K243508 FDA 510(k)
FDA Product Code
HGX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 884.5160 FDA 510(k)
Regulation Number
884.5160 FDA 510(k)
Advisory Committee
Obstetrics/Gynecology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

A wearable breast pump (model S12A) is an electrically powered, single-user device for expressing and collecting breast milk. It is classified as a Pump, Breast, Powered under FDA device class 2 and has received FDA 510(k) clearance under K243508. The device features three operation modes: Expression, Stimulation, and Auto, each with adjustable suction levels and cycle speeds.

The device is supplied as a single-user, non-sterile wearable system intended for use in home or clinical settings. It is not MRI safe unless explicitly stated, and no information on reusability, sterility, storage conditions, or specific sizes is provided in the data. Authorization is based on FDA 510(k) clearance (K243508) granted on 2025-04-21, with product code HGX and regulation number 884.5160.

Frequently asked questions

What is the wearable breast pump model S12A used for?

The wearable breast pump model S12A is an electrically powered device designed for expressing and collecting breast milk. It is intended for single-user use in home or clinical settings, allowing mothers to pump milk hands-free while wearing the device.

How is the wearable breast pump model S12A supplied and is it sterile?

The device is supplied as a single-user, non-sterile wearable system. It is not provided in a sterile condition and is intended for personal use by one individual, with no indication of sterilization or reprocessing for reuse.

What operation modes does the wearable breast pump model S12A offer?

The device features three operation modes: Expression, Stimulation, and Auto. Each mode includes adjustable suction levels and cycle speeds, allowing users to customize their pumping experience based on comfort and milk flow needs.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K243508 - Wearable breast pump (model S12A) | FDA 510 (k), Wearable breast pump (model S12A) (K243508) — FDA 510(k) | Innolitics, Wearable breast pump (model S12A) — FDA K243508, Wearable Breast Pump (S12A) | Medical Device Navigator, K243508 - Wearable breast pump (model S12A) | FDA 510 (k)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shenzhen TPH Technology Co., Ltd
FDA Applicant
Shenzhen TPH Technology Co., Ltd.

Sources (1)

  • FDA 510(k) K243508 24 fields · synced Sep 26, 2026