FDA.reportPublic FDA data

510(k) K250046

Device
Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617)
Applicant
Shenzhen Urion Technology Co., Ltd.
510(k) number
K250046
Product code
IRP
Decision
Substantially Equivalent (SESE)
Decision date
2025-04-25
Date received
2025-01-10
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
No

Applicant Contact#

Contact
Janice Ou
Address
Floor 4-6th Of Bldg. D, Jiale Science & Technology Indust Zn Chuang Wei Rd.,Heshuikou Community,Matian St.,Guangming Newd Shenzhen CN 518106 518106

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
K253064Air Pressure Therapy System (VU-IPC8M); Air Pressure Therapy System (VU-IPC6M); Air Pressure Therapy System (VU-IPC4X)Xiamen Weiyou Intelligent Technology Co., Ltd.2026-04-30
K252386Hot and Cold Compression System (A02-C-032)Chengdu Cryo-Push Medical Technology Co.,Ltd2026-04-03
K253076Cryopush Cold Compression Device (A02-P-001)Chengdu Cryo-Push Medical Technology Co.,Ltd2026-04-02
K251622Hand Massager (SM004D)Ningbo Zhenhai Yihao Electronic Technology Co., Ltd.2026-01-28
K251662Air Compression Therapy Device (ST-504); Air Compression Therapy Device (ST-505); Air Compression Therapy Device (ST-506); Air Compression Therapy Device (ST-507)Shenzhen Future Electronic Co., Ltd.2025-11-13
K251531AIR COMPRESSION BOOTS 1018195,1018196Merchsource, LLC2025-10-30
K253150Cryon-X Cold CompressionJkh Health Co., Ltd.2025-10-24
K251905Normatec Elite HipNormaTec Industries, LP2025-09-18
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
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