FDA.reportPublic FDA data

510(k) K253076

Device
Cryopush Cold Compression Device (A02-P-001)
Applicant
Chengdu Cryo-Push Medical Technology Co.,Ltd
510(k) number
K253076
Product code
IRP
Decision
Substantially Equivalent (SESE)
Decision date
2026-04-02
Date received
2025-09-23
Regulation
890.5650
Classification name
Massager, Powered Inflatable Tube
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Lifang Yan
Address
2, Zone 9 And 102, 105, Zone 20, Huayin Industrial Port #618, Kexing Rd. (West), Wenjiang District Chengdu CN 611137 611137

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code IRP#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K254200Air Compression Leg Massager (LF-FT001, LF-FT002-1, LF-FT003, LF-FT003-1, LF-FT004-1, LF-FT005-1, LF-FT006-1, LF-FT007, LF-FT008, LF-FT009, LF-FT010, LF-FT011, LF-FT012, LF-FT013, LF-FT014, LF-FT015, LF-FT016, UM-01, UM-02, UM-03, UM-03-1, UM-04-1, UM-05-1, UM-06-1, UM-07, UM-08, UM-09, UM-10, UM-11, UM-12, UM-13, UM-14, UM-15, UM-16, AI-01, AI-02, AI-03, AI-04, AI-05, AI-06, AI01, AI02, AI03, AI-07, AI-08, AI-09, AI-10, AI-11, AI-12, AI-13, AI-14)Wenzhou Lingfeng Electronic Technology Co., Ltd.2026-05-05
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K251531AIR COMPRESSION BOOTS 1018195,1018196Merchsource, LLC2025-10-30
K253150Cryon-X Cold CompressionJkh Health Co., Ltd.2025-10-24
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K251623Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061)Shenzhen Yicai Health Technology Co., Ltd.2025-09-17
K250244Compression Therapy Device (LGT-2210DS)Guangzhou Longest Medical Technology Co., Ltd.2025-07-25
K242615Intermittent pressure compression system (Compression Pump PT1005A; Leg Compression Cuffs; L-1001S, L-1001L, L-1001XL, L-1001XXL, L-1001XXXL)Xiamen Taotao Technology Co., Ltd.2025-07-23
K242754ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A)Zamar Medical D.O.O.2025-05-05
K250046Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617)Shenzhen Urion Technology Co., Ltd.2025-04-25
K242140Air Compression Leg Massager (K-705)Jiale Health Technology Shenzhen Co., Ltd.2025-03-17
K243206Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4, ACM-PLUS-A5, ACM-PLUS-A6)Sichuan Qianli-Beoka Medical Technology, Inc.2025-02-19