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Inarex Model 2D-LX

by Inarex Corporation

510(k) K080554

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK080554 Date27 Aug 2008ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
JFB
Device Class
Class II
Regulation
21 CFR Part 890.5880
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 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 Inarex Model 2D-LX is a multi-function physical therapy table designed for use in physical medicine settings. It functions as a table for therapeutic applications and incorporates thermal massage capabilities.

The device is supplied by Inarex Corporation and is classified as Class II under product code JFB. It is regulated under 21 CFR 890.5880 and received FDA 510(k) clearance on August 27, 2008, with the K080554 number. The device is intended for use in physical therapy environments.

Other devices from Inarex Corporation

Questions

AI-generated answers, 1 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 therapeutic functions does the INAREX Model 2D-LX provide?

    The table combines a standard physical therapy surface with built‑in thermal massage capability, allowing clinicians to perform positioning, stretching, and heat‑based massage treatments without needing separate equipment.

  • Is the INAREX Model 2D-LX supplied as a single unit or in components?

    The device is supplied by Inarex Corporation as a complete, ready‑to‑install table; all mechanical and thermal massage components are included, so no additional parts are required for basic operation.

  • What is the regulatory classification of the INAREX Model 2D-LX?

    It is classified as a Class II medical device under product code JFB, regulated by 21 CFR 890.5880, and received traditional FDA 510(k) clearance (K080554) on August 27 2008.

  • Can the INAREX Model 2D-LX be reused on multiple patients?

    Yes, the table is designed for repeated clinical use. It is not a single‑use item; proper cleaning and maintenance between patients ensure safe, ongoing operation in a physical therapy environment.