DVT Garment

FDA 510(k) K253386 · Vistar Medical Supplies Co., Ltd.

Substantially Equivalent

510(k) numberK253386

Submission

Device name
DVT Garment
Applicant
Vistar Medical Supplies Co., Ltd.
Shenzhen, CN
Received
September 30, 2025
Decision date
June 25, 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
JOW – Sleeve, Limb, Compressible
Device class
Class II (moderate risk)
Regulation
21 CFR 870.5800
Specialty
Cardiovascular

Other 510(k)s with product code JOW

510(k)DeviceApplicantDecision
K261807Sequential Circulator (SC-4004-DL, SC-4008-DL)JOW · Traditional Bio Compression Systems, Inc.09/11/2026SE
K254217AerloomJOW · Traditional Evolym, LLC08/31/2026SE
K253555Flexitouch® Plus Advanced Pneumatic Compression SystemJOW · Traditional Tactile Medical07/31/2026SE
K250242Compression Therapy Device (LGT-2202DVT)JOW · Traditional Guangzhou Longest Medical Technology Co., Ltd.04/24/2026SE
K254267NanoPress 760A-BT (760A-BT)JOW · Traditional Mego Afek , Ltd.02/24/2026SE
K250974Bio Arterial Deluxe (IC-BAP-DX)JOW · Traditional Bio Compression Systems, Inc.12/12/2025SE
K250190Sequential Compression System (SCD600)JOW · Traditional Shenzhen Comen Medical Instruments Co.,Ltd12/08/2025SE
K251466VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System…JOW · Special Wellell, Inc.10/28/2025SE
K251446PlasmaFlow X Compression Sleeve Device (XPF0001)JOW · Special Manamed, LLC09/17/2025SE
K251086PnueAira (PNCU-01)JOW · Traditional Biotab, LLC08/18/2025SE

Questions and answers

When was DVT Garment cleared by the FDA?

DVT Garment (K253386) received a 510(k) decision of Substantially Equivalent on June 25, 2026, 268 days after the submission was received.

What is the product code of K253386?

The FDA product code is JOW – Sleeve, Limb, Compressible, a Class II (moderate risk) device regulated under 21 CFR 870.5800.