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StimSox System

by Stimmed, LLC 2 variants

510(k) K171071

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 NumberK171071 Date9 Aug 2017ClearedStatusActive

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  • Withdrawn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)

Full name
StimSox(TM) System
510(k) Number
FDA Product Code
IPF
Device Class
Class II
Regulation
21 CFR Part 890.5850
Advisory Committee
Physical Medicine
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 StimSox System is a device that temporarily increases local blood circulation in healthy leg muscles and provides immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. It is comprised of a battery-powered electrical stimulator, disposable gel electrodes, and foot boots. The system is designed to stimulate blood flow in healthy legs. The StimSox System includes a stimulator with embedded firmware for input controls and output display.

The StimSox System is supplied with a user manual, AAA batteries, and disposable gel electrodes. It is a single device with specific components, including two left foot boots and two right foot boots. The system has received FDA 510K authorization. The device is designed for use in increasing blood flow in healthy leg muscles.

Other devices from Stimmed, LLC

Questions

AI-generated answers, 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.

  • What is the StimSox System used for?

    The StimSox System is used to temporarily increase local blood circulation in healthy leg muscles and provide immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

  • How is the StimSox System supplied?

    The StimSox System is supplied with a user manual, AAA batteries, and disposable gel electrodes, including two left foot boots and two right foot boots.

  • Is the StimSox System single-use or reusable?

    The StimSox System includes disposable gel electrodes, indicating that some components are single-use, while the stimulator itself is reusable.

  • What are the regulatory authorizations for the StimSox System?

    The StimSox System has received FDA 510K authorization, indicating that it is substantially equivalent to a predicate device.