Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Wearable Breast Pump (Model S36)

K-Number: K254203 · 2026-09-17

ApplicantShenzhen TPH Technology Co., Ltd.
Decision Date2026-09-17
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Wearable Breast Pump (Model S36) 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 2026-09-17 under 510(k) number K254203. 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 Wearable Breast Pump (Model S36)?

Wearable Breast Pump (Model S36) is a medical device that received FDA 510(k) clearance on 2026-09-17. The listed applicant is Shenzhen TPH Technology Co., Ltd.. The 510(k) number is K254203.

When did Wearable Breast Pump (Model S36) receive FDA 510(k) clearance?

Wearable Breast Pump (Model S36) received FDA 510(k) clearance on 2026-09-17, under 510(k) number K254203.

Who is the listed applicant for Wearable Breast Pump (Model S36)?

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 Wearable Breast Pump (Model S36)?

The FDA product code for Wearable Breast Pump (Model S36) is HGX.

Related Clinical Trials

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.

NCT05147987Improving Lactation Success in Black Mothers of Critically Ill InfantsCOMPLETED

Other records listing Shenzhen TPH Technology 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.

K260259DiscreetDuo™ Flow Wearable Breast Pump (Model S3)K261199Wearable Breast Pump (Model S32A)K260864Mother's Nature W1 Warming Wearable Breast PumpK254244Wearable Breast Pump (Model S39)K260033Wearable Breast Pump (Model S21A)K252422Wearable Breast Pump (Model W2)

View all 24 devices →

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.

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.K261199Wearable Breast Pump (Model S32A)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.

↑