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Heelsafe DVT Hose, Models 00800-00804, 00805-00809

by Dm Systems, Incorporated 510(k)

Active United States

510(k) K101614

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK101614 Date13 Jan 2011ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DWL
Device Class
Class II
Regulation
21 CFR Part 880.5780
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The device is a stocking, medical support (to prevent pooling of blood in legs) as classified under regulation 880.5780. It is designed to aid and prevent deep vein thrombosis in recumbent patients with limited mobility through progressive compression from foot to knee to improve venous return and avoid clot formation.

It is supplied as a medical device under FDA 510(k) clearance K101614, product code DWL, and is classified as a Class II device. The device is intended for use in general hospital settings.