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Lordex Lumbar Extension Machine

by Lordex, Inc.

510(k) K930735

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 NumberK930735 Date29 Sep 1994ClearedStatusActive

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  • Withdrawn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
ISD
Device Class
Class II
Regulation
21 CFR Part 890.5360
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 Lordex Lumbar Extension Machine is an exerciser device designed to strengthen the muscles of the lumbar spine. It provides eccentric and concentric range of motion to help stabilize the spine and address muscle weakness and instability.

This device is manufactured by Lordex, Inc. and is a Class II medical device with FDA 510(k) clearance. It is intended for professional use in physical medicine settings and is supplied as a reusable device. The device is available in various models as indicated by the multiple registration numbers associated with it.

Questions

AI-generated answers, 24 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 Lordex Lumbar Extension Machine used for?

    The Lordex Lumbar Extension Machine is designed to strengthen the muscles of the lumbar spine by providing eccentric and concentric range of motion, which helps stabilize the spine and address muscle weakness and instability in professional physical medicine settings.

  • Is the Lordex Lumbar Extension Machine reusable or single-use?

    The Lordex Lumbar Extension Machine is supplied as a reusable device, intended for repeated use in clinical or professional environments after appropriate cleaning and maintenance between uses.

  • What type of medical device is the Lordex Lumbar Extension Machine and how was it cleared?

    The Lordex Lumbar Extension Machine is a Class II medical device that received FDA 510(k) clearance, determined to be substantially equivalent to a predicate device, and is used for exercising the lumbar spine in physical medicine applications.