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Spectra Wearable 2

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K250208

by Uzinmedicare Co., Ltd.

Identifiers

510(k) Number
K250208 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)

The Spectra Wearable 2 is a powered breast pump, classified as a Class II medical device. It is designed to assist in the expression of breast milk for lactating individuals, providing a non-invasive method for milk removal and storage.

This device is intended for use in clinical and home settings, supplied as a reusable system with disposable components. It has received FDA 510(k) clearance and MDR authorization, adhering to regulatory standards for obstetrics and gynecology applications. The device operates under specific registration numbers and is categorized under the product code HGX, with no third-party involvement in its review.

Frequently asked questions

What is the primary use of the Spectra Wearable 2 and where can it be used?

The Spectra Wearable 2 is a powered breast pump designed to assist lactating individuals in expressing breast milk non-invasively. It is intended for use in both clinical settings, such as hospitals or lactation centers, and home environments, providing flexibility for milk removal and storage.

Is the Spectra Wearable 2 a single-use or reusable device, and what components are disposable?

The Spectra Wearable 2 is supplied as a reusable system, but it includes disposable components that must be replaced after each use. This design balances convenience and hygiene for users.

What regulatory approvals does the Spectra Wearable 2 hold, and how does this affect its availability?

The Spectra Wearable 2 has received FDA 510(k) clearance and MDR authorization, confirming its compliance with U.S. and European regulatory standards for Class II medical devices. These approvals validate its safety and performance for obstetrics and gynecology applications, ensuring it meets stringent quality and efficacy requirements.

Are there different models or sizes available for the Spectra Wearable 2, and how would I determine the right fit?

The Spectra Wearable 2 is listed with multiple registration numbers (e.g., 3012298445, 3024790242, etc.), which may correspond to variations in design or features. While specific sizing details are not provided, the device is categorized under product code HGX for breast pumps, suggesting compatibility with standard breast shapes. Consulting the manufacturer’s guidelines or a healthcare provider would help determine the best fit for individual 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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Uzinmedicare Co., Ltd.

Sources (2)

  • FDA 510(k) K250208 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced Jun 4, 2026