DVT Garment— 510(k) K253386
Substantially EquivalentVistar Medical Supplies Co., Ltd.
FDA 510(k) clearance K253386 for DVT Garment, Substantially Equivalent on 2026-06-25. Applicant: Vistar Medical Supplies Co., Ltd.. Device class: 2.
Summary
Vistar Medical Supplies' DVT Garment is filed under JOW, compressible limb sleeves. The name is generic, and the record gives no model numbers or sizes.
Class II, 21 CFR 870.5800. Cardiovascular is both the classification panel and the review panel. The submission was a Traditional 510(k).
Vistar filed from Shenzhen, China. The decision came 268 calendar days after receipt (September 30, 2025 to June 25, 2026).
Clearance details
- Applicant
- Vistar Medical Supplies Co., Ltd.
- Product code
- Product code JOW
- Device class
- Class 2
- Regulation
- 21 CFR 870.5800
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Recent devices under product code JOW
view allData sourced from openFDA. This site is unofficial and independent of the FDA.