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Medcomp Mc 5 Gradient Sequential Pump

by Yoav Gershoni

510(k) K953516

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)SN Traditional NumberK953516 Date8 Dec 1995DecidedStatusActive

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  • Withdrawn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
IRP
Device Class
Class II
Regulation
21 CFR Part 890.5650
Advisory Committee
Physical Medicine
FDA Decision
SN

Overview

AI-generated summary, 22 Sep 2026

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

The Medcomp Mc 5 Gradient Sequential Pump is a massager, powered inflatable tube, classified under the medical specialty of Physical Medicine. It is substantially equivalent for some indications. The device is a type of sequential compression pump, which works with the movement of the calf muscle to push fluid and blood back up through the body.

The Medcomp Mc 5 Gradient Sequential Pump is supplied with a product code of IRP and a regulation number of 890.5650. It has been assigned a k number of K953516 and is classified as a device with FDA 510(k) clearance. The device is intended for use in a medical setting and is subject to the regulations and guidelines set forth by the FDA.

Questions

AI-generated answers, 22 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 Medcomp Mc 5 Gradient Sequential Pump used for?

    The Medcomp Mc 5 Gradient Sequential Pump is used to push fluid and blood back up through the body, working with the movement of the calf muscle, in a medical setting.

  • Is the Medcomp Mc 5 Gradient Sequential Pump supplied sterile?

    The device data does not specify if the Medcomp Mc 5 Gradient Sequential Pump is supplied sterile, but it is classified under the medical specialty of Physical Medicine and has a product code of IRP.

  • What is the regulatory classification of the Medcomp Mc 5 Gradient Sequential Pump?

    The Medcomp Mc 5 Gradient Sequential Pump has been assigned a regulation number of 890.5650 and a k number of K953516, indicating it has FDA 510(k) clearance as a class 2 device.