FDA 510(k)

Motif Aura Glow breast pump (Model Motif Aura Glow)

K-번호: K250365 · 2025-05-30

결정일2025-05-30

제품 코드HGX

자문 위원회OB

결정Substantially Equivalent

기기 요약

Motif Aura Glow breast pump (Model Motif Aura Glow) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen TPH Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-05-30 under 510(k) number K250365. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Motif Aura Glow breast pump (Model Motif Aura Glow)?

Motif Aura Glow breast pump (Model Motif Aura Glow) is a medical device that received FDA 510(k) clearance on 2025-05-30. The listed applicant is Shenzhen TPH Technology Co., Ltd.. The 510(k) number is K250365.

When did Motif Aura Glow breast pump (Model Motif Aura Glow) receive FDA 510(k) clearance?

Motif Aura Glow breast pump (Model Motif Aura Glow) received FDA 510(k) clearance on 2025-05-30, under 510(k) number K250365.

Who is the listed applicant for Motif Aura Glow breast pump (Model Motif Aura Glow)?

The FDA 510(k) record lists Shenzhen TPH Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Motif Aura Glow breast pump (Model Motif Aura Glow)?

The FDA product code for Motif Aura Glow breast pump (Model Motif Aura Glow) is HGX.

Shenzhen TPH Technology Co., Ltd.를 신청인으로 등재한 기타 기록

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