Decision Date2017-12-20
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Electric Breast Pump is the device name listed in this FDA 510(k) record. The listed applicant is Joytech Healthcare Co. , Ltd.. It received FDA 510(k) clearance on 2017-12-20 under 510(k) number K172989. 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 Electric Breast Pump?
Electric Breast Pump is a medical device that received FDA 510(k) clearance on 2017-12-20. The listed applicant is Joytech Healthcare Co. , Ltd.. The 510(k) number is K172989.
When did Electric Breast Pump receive FDA 510(k) clearance?
Electric Breast Pump received FDA 510(k) clearance on 2017-12-20, under 510(k) number K172989.
Who is the listed applicant for Electric Breast Pump?
The FDA 510(k) record lists Joytech Healthcare Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Electric Breast Pump?
The FDA product code for Electric Breast Pump is HGX.
Related Clinical Trials
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Other records listing Joytech Healthcare Co. , Ltd. 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.
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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.
K254203Wearable Breast Pump (Model S36)Shenzhen TPH Technology Co., Ltd.K261622Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62); Philips Avent Natural Care Warming Hands-free Wearable Electric Breast Pump (Model: SCF594/52, SCF594/62)Philips Consumer Lifestyle B.V.K262774Wearable breast pump (Model: XN/MD-2249BS, ZFHF)Guangdong Horigen Mother & Baby Products Co., Ltd.K260643Cimilre Dual MaxCimilre Co., Ltd.K261298Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))Guangdong Youmeng Electrical Technology Co., Ltd.K260259DiscreetDuo™ Flow Wearable Breast Pump (Model S3)Shenzhen TPH 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.