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FDA 510(k)

Air Compression Therapy Device

K-Number: K193354 · 2020-06-08

ApplicantShenzhen Dongjilian Electronics Co., Ltd.
Decision Date2020-06-08
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Air Compression Therapy Device is a medical device manufactured by Shenzhen Dongjilian Electronics Co., Ltd.. It received FDA 510(k) clearance on 2020-06-08 under approval number K193354. 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 Air Compression Therapy Device?

Air Compression Therapy Device is a medical device that received FDA 510(k) clearance on 2020-06-08. It is manufactured by Shenzhen Dongjilian Electronics Co., Ltd.. The 510(k) number is K193354.

When was Air Compression Therapy Device approved by the FDA?

Air Compression Therapy Device received FDA 510(k) clearance on 2020-06-08, under approval number K193354.

What company makes Air Compression Therapy Device?

Air Compression Therapy Device is manufactured by Shenzhen Dongjilian Electronics Co., Ltd..

What is the FDA product code for Air Compression Therapy Device?

The FDA product code for Air Compression Therapy Device is IRP.

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Related PubMed Literature

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: 40290478 Mental health apps in India: regulatory landscape and future directions. BJPsych international (2025)

Other Devices by Shenzhen Dongjilian Electronics Co., Ltd.

K201694Air Compression Therapy Device K200354Electronic stimulator

Related Devices (Code: IRP)

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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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