Hot and Cold Compression System (A02-C-032)

FDA 510(k) K252386 · Chengdu Cryo-Push Medical Technology Co.,Ltd

Substantially Equivalent

510(k) numberK252386

Submission

Device name
Hot and Cold Compression System (A02-C-032)
Applicant
Chengdu Cryo-Push Medical Technology Co.,Ltd
611137, CN
Received
July 31, 2025
Decision date
April 3, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary 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

Other 510(k)s with product code IRP

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K260948Air Compression Massager (EP30B001 I)IRP · Traditional Wavepulse (Xiamen) Healthcare Technology Co., Ltd.07/24/2026SE
K253919Cryo And Thermo Therapy SystemIRP · Traditional Xiamen Weiyou Intelligent Technology Co., Ltd.06/10/2026SE
K252396Cryo Sport 2.0 (AVA 501)IRP · Traditional Avanutri Equipamentos DE Saúde05/29/2026SE
K254200Air Compression Leg Massager (LF-FT001, LF-FT002-1, LF-FT003, LF-FT003-1, LF-FT004-1…IRP · Traditional Wenzhou Lingfeng Electronic Technology Co., Ltd.05/05/2026SE
K253064Air Pressure Therapy System (VU-IPC8M); Air Pressure Therapy System (VU-IPC6M); Air…IRP · Traditional Xiamen Weiyou Intelligent Technology Co., Ltd.04/30/2026SE
K253076Cryopush Cold Compression Device (A02-P-001)IRP · Traditional Chengdu Cryo-Push Medical Technology Co.,Ltd04/02/2026SE
K251622Hand Massager (SM004D)IRP · Traditional Ningbo Zhenhai Yihao Electronic Technology Co.…01/28/2026SE
K251662Air Compression Therapy Device (ST-504); Air Compression Therapy Device (ST-505); Air…IRP · Traditional Shenzhen Future Electronic Co., Ltd.11/13/2025SE

More from Shenzhen Future Electronic Co., Ltd.

510(k)DeviceDecision
K253076Cryopush Cold Compression Device (A02-P-001)IRP · Traditional 04/02/2026SE
K230524Cold Compression Wrap ProIRP · Traditional 01/19/2024SE
K222669Cryopush Cold Compression DeviceIRP · Traditional 12/05/2022SE

Questions and answers

When was Hot and Cold Compression System (A02-C-032) cleared by the FDA?

Hot and Cold Compression System (A02-C-032) (K252386) received a 510(k) decision of Substantially Equivalent on April 3, 2026, 246 days after the submission was received.

What is the product code of K252386?

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