Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061)

FDA 510(k) K251623 · Shenzhen Yicai Health Technology Co., Ltd.

Substantially Equivalent

510(k) numberK251623

Submission

Device name
Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061)
Applicant
Shenzhen Yicai Health Technology Co., Ltd.
Shenzhen, CN
Received
May 28, 2025
Decision date
September 17, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
IRP – Massager, Powered Inflatable Tube
Device class
Class II (moderate risk)
Regulation
21 CFR 890.5650
Specialty
Physical Medicine

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K253064Air Pressure Therapy System (VU-IPC8M); Air Pressure Therapy System (VU-IPC6M); Air…IRP · Traditional Xiamen Weiyou Intelligent Technology Co., Ltd.04/30/2026SE
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More from Ningbo Zhenhai Yihao Electronic Technology Co., Ltd.

510(k)DeviceDecision
K250784Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/ K6137/ K6138/…NUH · Traditional 08/21/2025SE
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Questions and answers

When was Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061) cleared by the FDA?

Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061) (K251623) received a 510(k) decision of Substantially Equivalent on September 17, 2025, 112 days after the submission was received.

What is the product code of K251623?

The FDA product code is IRP – Massager, Powered Inflatable Tube, a Class II (moderate risk) device regulated under 21 CFR 890.5650.