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FDA 510(k)

Leg and Foot Air Wave Pressure Therapy Device

K-Number: K223464 · 2023-03-14

ApplicantZhangzhou Easepal Innovation CO , Ltd.
Decision Date2023-03-14
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Leg and Foot Air Wave Pressure Therapy Device is a medical device manufactured by Zhangzhou Easepal Innovation CO , Ltd.. It received FDA 510(k) clearance on 2023-03-14 under approval number K223464. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Leg and Foot Air Wave Pressure Therapy Device?

Leg and Foot Air Wave Pressure Therapy Device is a medical device that received FDA 510(k) clearance on 2023-03-14. It is manufactured by Zhangzhou Easepal Innovation CO , Ltd.. The 510(k) number is K223464.

When was Leg and Foot Air Wave Pressure Therapy Device approved by the FDA?

Leg and Foot Air Wave Pressure Therapy Device received FDA 510(k) clearance on 2023-03-14, under approval number K223464.

What company makes Leg and Foot Air Wave Pressure Therapy Device?

Leg and Foot Air Wave Pressure Therapy Device is manufactured by Zhangzhou Easepal Innovation CO , Ltd..

What is the FDA product code for Leg and Foot Air Wave Pressure Therapy Device?

The FDA product code for Leg and Foot Air Wave Pressure Therapy Device is IRP.

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Related PubMed Literature

PMID: 41836285 A Case Study of AI-Enabled Software as a Medical Device Cleared by the FDA for Assessing Hemorrhage Risk Index (APPRAISE-HRI) after Trauma. NEJM AI (2025) PMID: 41072144 Use of Bayesian decision analysis in the design of patient-centered clinical trials for kidney failure devices. Computers in biology and medicine (2025) PMID: 41040861 Enhancing post-operative hypothyroidism treatment: rat thyroid autotransplantation into a pre-vascularized, retrievable cell pouch™ device. Frontiers in endocrinology (2025) PMID: 40610624 Impact of a novel smartphone application for remote monitoring of gestational diabetes on glycaemic control and birth outcomes: a pilot observational study. Scientific reports (2025)

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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.

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