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)

Elvie Stride

K-Number: K210936 · 2021-08-25

ApplicantChiaro Technology Limited
Decision Date2021-08-25
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Elvie Stride is the device name listed in this FDA 510(k) record. The listed applicant is Chiaro Technology Limited. It received FDA 510(k) clearance on 2021-08-25 under 510(k) number K210936. 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 Elvie Stride?

Elvie Stride is a medical device that received FDA 510(k) clearance on 2021-08-25. The listed applicant is Chiaro Technology Limited. The 510(k) number is K210936.

When did Elvie Stride receive FDA 510(k) clearance?

Elvie Stride received FDA 510(k) clearance on 2021-08-25, under 510(k) number K210936.

Who is the listed applicant for Elvie Stride?

The FDA 510(k) record lists Chiaro Technology Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Elvie Stride?

The FDA product code for Elvie Stride is HGX.

Other records listing Chiaro Technology Limited 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.

K242125Elvie Stride 2K181863Elvie Pump

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.

K260259DiscreetDuo™ Flow Wearable Breast Pump (Model S3)Shenzhen TPH Technology Co., Ltd.K261199Wearable Breast Pump (Model S32A)Shenzhen TPH Technology Co., Ltd.K250070Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)Shenzhen Changkun Technology Co., Ltd.K261025Wearable breast pump (QY-101, QY-102, QY-108)Shenzhen Qinyi Electronic Technology Co., Ltd.K254254Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)Shenzhen Root Innovation Technology Co., Ltd.K260538Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )Shenzhen Root Innovation 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.

↑