FDA.reportPublic FDA data

510(k) K253386

Device
DVT Garment
Applicant
Vistar Medical Supplies Co., Ltd.
510(k) number
K253386
Product code
JOW
Decision
Substantially Equivalent (SESE)
Decision date
2026-06-25
Date received
2025-09-30
Regulation
870.5800
Classification name
Sleeve, Limb, Compressible
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Chainy Chen
Address
101, 201 &301, #5 Facility, Datianyang Nansi Rd. Dongfang Community, Songgang St., Bao'An District Shenzhen CN 518105 518105

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JOW#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250242Compression Therapy Device (LGT-2202DVT)Guangzhou Longest Medical Technology Co., Ltd.2026-04-24
K254267NanoPress 760A-BT (760A-BT)Mego Afek , Ltd.2026-02-24
K250974Bio Arterial Deluxe (IC-BAP-DX)Bio Compression Systems, Inc.2025-12-12
K250190Sequential Compression System (SCD600)Shenzhen Comen Medical Instruments Co.,Ltd2025-12-08
K251466VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System (PM01D01 / Calf garment (S)); VenAir, Sequential Compression System (PM01E01 / Calf garment (M)); VenAir, Sequential Compression System (PM01F01 / Calf garment (L)); VenAir, Sequential Compression System (PM01G01 / Thigh garment (S)); VenAir, Sequential Compression System (PM01H01 / Thigh garment (M)); VenAir, Sequential Compression System (PM01I01 / Thigh garment (L)); VenAir, Sequential ComprWellell, Inc.2025-10-28
K251446PlasmaFlow X Compression Sleeve Device (XPF0001)Manamed, LLC2025-09-17
K251086PnueAira (PNCU-01)Biotab, LLC2025-08-18
K250817Coretech Compression System (Coretech RHB3003)Vive Health, LLC2025-08-08
K241096Venera 608 Deep Vein Thrombosis (DVT) Prevention SystemSuzhou Minhua Medical Apparatus Supplies Co., Ltd.2025-01-15
K240499ARTAIRA Arterial Compression Device (AACD01)Airos Medical, Inc.2024-10-11
K241746UMED REPROCESSED AIRCAST VENAFLOW FOOT CUFF; UMED REPROCESSED KENDALL SCD EXPRESS SLEEVE; UMED REPROCESSED AIRCAST ELITE CALF CUFF 3040 3050; UMED REPROCESSED CTC VP 501 CALF CUFF; UMED REPROCESSED CTC VP 520 FOOT CUFFUnited Medical Resources, LLC2024-10-04
K232640Venowave VW5Thermabright2024-06-25
K234155Nimbl (model PD08-N1)Tactile Medical2024-06-21
K240125Therm-X (Home); Therm-X (AT)Zenith Technical Innovations2024-06-21
K232270DVT Motion Pneumatic Compression DeviceKoge Micro Tech Co., Ltd.2024-03-06