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FDA 510(k)

Air Compression Therapy System

K-Number: K192466 · 2020-06-22

ApplicantShenzhen Lifotronic Technology Co., Ltd.
Decision Date2020-06-22
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Air Compression Therapy System is a medical device manufactured by Shenzhen Lifotronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-06-22 under approval number K192466. 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 System?

Air Compression Therapy System is a medical device that received FDA 510(k) clearance on 2020-06-22. It is manufactured by Shenzhen Lifotronic Technology Co., Ltd.. The 510(k) number is K192466.

When was Air Compression Therapy System approved by the FDA?

Air Compression Therapy System received FDA 510(k) clearance on 2020-06-22, under approval number K192466.

What company makes Air Compression Therapy System?

Air Compression Therapy System is manufactured by Shenzhen Lifotronic Technology Co., Ltd..

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

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

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Related PubMed Literature

PMID: 38493931 Establishing finite element model credibility of a pedicle screw system under compression-bending: An end-to-end example of the ASME V&V 40 standard. Methods (San Diego, Calif.) (2024) PMID: 35685299 Multicenter, Double-Blinded, Randomized, Active-Sham Controlled Clinical Study Design to Assess the Safety and Effectiveness of a Novel High Frequency Electric Nerve Block System in the Treatment of Post-Amputation Pain (The QUEST Study). Journal of pain research (2022) PMID: 35047938 Evolution of the Vagus Nerve Stimulation (VNS) Therapy System Technology for Drug-Resistant Epilepsy. Frontiers in medical technology (2021) PMID: 29653650 Comparison of adverse event and device problem rates for transcatheter aortic valve replacement and Mitraclip procedures as reported by the Transcatheter Valve Therapy Registry and the Food and Drug Administration postmarket surveillance data. American heart journal (2018)

Other Devices by Shenzhen Lifotronic Technology Co., Ltd.

K251076Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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