FDA 510(k)

SPECTRA可穿戴2

K号: K250208 · 2026-04-06

决定日期2026-04-06

产品代码HGX

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决定实质等同

器械摘要

SPECTRA Wearable 2 is the device name listed in this FDA 510(k) record. The listed applicant is Uzinmedicare Co., Ltd.. It received FDA 510(k) clearance on 2026-04-06 under 510(k) number K250208. 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 SPECTRA Wearable 2?

SPECTRA Wearable 2 is a medical device that received FDA 510(k) clearance on 2026-04-06. The listed applicant is Uzinmedicare Co., Ltd.. The 510(k) number is K250208.

When did SPECTRA Wearable 2 receive FDA 510(k) clearance?

SPECTRA Wearable 2 received FDA 510(k) clearance on 2026-04-06, under 510(k) number K250208.

Who is the listed applicant for SPECTRA Wearable 2?

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

What is the FDA product code for SPECTRA Wearable 2?

The FDA product code for SPECTRA Wearable 2 is HGX.

列明Uzinmedicare 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。

K260956Spectra Platinum Mini K251423Spectra S1 Pro; Spectra S2 Pro K251932Spectra Platinum K220926Spectra Wearable

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

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