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FDA 510(k)

eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03)

K-Number: K250207 · 2025-08-11

ApplicantAnker Innovations Limited
Decision Date2025-08-11
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03) is a medical device manufactured by Anker Innovations Limited. It received FDA 510(k) clearance on 2025-08-11 under approval number K250207. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03)?

eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03) is a medical device that received FDA 510(k) clearance on 2025-08-11. It is manufactured by Anker Innovations Limited. The 510(k) number is K250207.

When was eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03) approved by the FDA?

eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03) received FDA 510(k) clearance on 2025-08-11, under approval number K250207.

What company makes eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03)?

eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03) is manufactured by Anker Innovations Limited.

What is the FDA product code for eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03)?

The FDA product code for eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03) is HGX.

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Related Devices (Code: HGX)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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