FDA 510(k)

可穿戴式吸奶器（型号FS12A）；可穿戴式吸奶器（型号FS12B）

K号: K250843 · 2025-07-31

决定日期2025-07-31

产品代码HGX

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决定实质等同

器械摘要

Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B) 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 2025-07-31 under 510(k) number K250843. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B)?

Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B) is a medical device that received FDA 510(k) clearance on 2025-07-31. The listed applicant is Shenzhen TPH Technology Co., Ltd.. The 510(k) number is K250843.

When did Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B) receive FDA 510(k) clearance?

Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B) received FDA 510(k) clearance on 2025-07-31, under 510(k) number K250843.

Who is the listed applicant for Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B)?

FDA 510(k)记录将深圳TPH科技有限公司列为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B)?

The FDA product code for Wearable Breast Pump (Model FS12A); Wearable Breast Pump (Model FS12B) is HGX.

列明Shenzhen TPH Technology Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K254203可穿戴式乳腺泵（型号S36）K260259DiscreetDuo™ 流动式穿戴型乳房吸奶器（型号 S3）K261199可穿戴式乳腺泵（型号S32A）K260864Mother's Nature W1保暖可穿戴吸奶器 K254244可穿戴式乳腺泵（型号S39）K260033可穿戴式乳腺泵（型号S21A）

查看所有 24 个设备 →

相关器械（代码：HGX）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K254203可穿戴式乳腺泵（型号S36）Shenzhen TPH Technology Co., Ltd.K261622飞利浦新安怡自然护理免手提电动吸奶器（型号：SCF593/52，SCF593/62）；飞利浦新安怡自然护理加热免手提电动吸奶器（型号：SCF594/52，SCF594/62）Philips Consumer Lifestyle B.V.K262774可穿戴式乳腺泵（型号：XN/MD-2249BS，ZFHF）Guangdong Horigen Mother & Baby Products Co., Ltd.K260643Cimilre 双重最大Cimilre Co., Ltd.K261298可穿戴电动吸奶器（YM-8837，YM-8838，YM-8856(H03)，YM-8809(S42)）Guangdong Youmeng Electrical Technology Co., Ltd.K260259DiscreetDuo™ 流动式穿戴型乳房吸奶器（型号 S3）Shenzhen TPH Technology Co., Ltd.

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。