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FDA 510(k)

VIVACE

K-Number: K242111 · 2025-02-06

ApplicantUnimom.Co
Decision Date2025-02-06
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

VIVACE is the device name listed in this FDA 510(k) record. The listed applicant is Unimom.Co. It received FDA 510(k) clearance on 2025-02-06 under 510(k) number K242111. 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 VIVACE?

VIVACE is a medical device that received FDA 510(k) clearance on 2025-02-06. The listed applicant is Unimom.Co. The 510(k) number is K242111.

When did VIVACE receive FDA 510(k) clearance?

VIVACE received FDA 510(k) clearance on 2025-02-06, under 510(k) number K242111.

Who is the listed applicant for VIVACE?

The FDA 510(k) record lists Unimom.Co as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VIVACE?

The FDA product code for VIVACE is HGX.

Other records listing Unimom.Co as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232047VIVACEK190810OPERA, OPERA ecoK180075MINUET LCD, MINUET LCD eco

Related Devices (Code: HGX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260259DiscreetDuo™ Flow Wearable Breast Pump (Model S3)Shenzhen TPH Technology Co., Ltd.K261199Wearable Breast Pump (Model S32A)Shenzhen TPH Technology Co., Ltd.K250070Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)Shenzhen Changkun Technology Co., Ltd.K261025Wearable breast pump (QY-101, QY-102, QY-108)Shenzhen Qinyi Electronic Technology Co., Ltd.K254254Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)Shenzhen Root Innovation Technology Co., Ltd.K260538Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )Shenzhen Root Innovation Technology Co., Ltd.

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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