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FDA 510(k)

Air Compression Therapy System

K-Number: K192466 · 2020-06-22

Decision Date2020-06-22
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Air Compression Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Lifotronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-06-22 under 510(k) 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. The listed applicant is Shenzhen Lifotronic Technology Co., Ltd.. The 510(k) number is K192466.

When did Air Compression Therapy System receive FDA 510(k) clearance?

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

Who is the listed applicant for Air Compression Therapy System?

The FDA 510(k) record lists Shenzhen Lifotronic Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Shenzhen Lifotronic 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.

Related Devices (Code: IRP)

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.

Official Source

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