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Flight Sock

by Ssl Americas, Inc.

510(k) K040353

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK040353 Date11 Mar 2004ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

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, 19 Sep 2026

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

Flight Sock is a medical support stocking designed to prevent pooling of blood in the legs. It is classified under the device name Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) and is intended for use in general hospital settings.

The device was cleared via the FDA 510(k) pathway under K040353 with a substantially equivalent decision. It is supplied as a reusable or single-use item (as implied by its classification and lack of sterility claims), with no MRI safety information provided in the data. Storage and handling instructions are not specified in the available data.

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Questions

AI-generated answers, 19 Sep 2026

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

  • What is the Flight Sock intended to do?

    The Flight Sock is a medical support stocking designed to prevent pooling of blood in the legs, as stated in its device description and classification under Stocking, Medical Support (To Prevent Pooling Of Blood In Legs).

  • Is the Flight Sock supplied as a sterile or non-sterile device?

    The Flight Sock is supplied as a non-sterile device, as there are no sterility claims mentioned in the device data, and it is described as reusable or single-use based on its classification and lack of sterility information.

  • How was the Flight Sock cleared for marketing in the United States?

    The Flight Sock was cleared via the FDA 510(k) pathway under submission K040353, receiving a substantially equivalent (SESE) decision on March 11, 2004, based on its classification as a Class II medical device.

  • What setting is the Flight Sock intended for use in?

    The Flight Sock is intended for use in general hospital settings, as indicated by its device description and the advisory committee classification of 'General Hospital' in the authorization data.

  • Does the device data provide information on MRI safety or storage requirements for the Flight Sock?

    No, the device data does not include any MRI safety information or specified storage and handling instructions for the Flight Sock.