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Aerolet Toilet Lift, Model AER-01

by Economic Holland B.V.

510(k) K031045

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K031045↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Traditional NumberK031045 Date10 Jul 2003ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
INO
Device Class
Class II
Regulation
21 CFR Part 890.3110
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 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 Aerolet Toilet Lift, Model AER-01, is an electric positioning chair designed to assist individuals with limited mobility in safely transferring to and from a toilet seat. Classified as a Chair, Positioning, Electric, it provides adjustable support to enhance independence and reduce strain during bathroom use.

This device is intended for use in home or clinical settings and is supplied as a reusable, non-sterile product. It complies with FDA 510(k) clearance under the Physical Medicine advisory committee and EU MDR regulations. The lift features a durable construction and is intended for use by trained caregivers or individuals with sufficient mobility to operate the controls.

Questions

AI-generated answers, 18 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 primary purpose of the Aerolet Toilet Lift, Model AER-01, and where can it be used?

    The Aerolet Toilet Lift, Model AER-01, is designed to assist individuals with limited mobility by providing adjustable electric support during transfers to and from a toilet seat. It enhances independence and reduces physical strain for users. This device is intended for use in both home and clinical settings, making it versatile for various environments where bathroom assistance is needed.

  • Is the Aerolet Toilet Lift reusable or single-use, and what does that mean for maintenance?

    The Aerolet Toilet Lift is a reusable device, meaning it is not intended for single-use disposal. This design allows for repeated use over time, but it also implies that users or caregivers will need to follow manufacturer guidelines for cleaning and maintenance to ensure hygiene and longevity. Since it is non-sterile, regular cleaning is recommended to prevent contamination.

  • How is the regulatory approval for this device structured, and what does that tell buyers about its compliance?

    The Aerolet Toilet Lift holds both FDA 510(k) clearance and EU MDR compliance, indicating it has undergone rigorous review processes in both the United States and Europe. The FDA clearance under the Physical Medicine advisory committee confirms it meets U.S. safety and performance standards, while MDR compliance ensures adherence to European Union regulations. This dual approval provides confidence in its regulatory standing for global use.

  • What does the classification as a 'Chair, Positioning, Electric' imply about how this device is intended to function?

    The classification as a 'Chair, Positioning, Electric' means this device is specifically engineered to provide adjustable, powered support for positioning users in a seated position, particularly during transfers to and from a toilet. The electric functionality allows for controlled movement and height adjustments, which helps caregivers or users with limited mobility achieve safer and more independent bathroom use.

  • Are there different sizes or models of the Aerolet Toilet Lift available, or is it a one-size-fits-all design?

    The provided data does not specify multiple sizes or models for the Aerolet Toilet Lift, Model AER-01. Based on the information, this appears to be a singular design intended for general use in home or clinical settings. If specific sizing needs are critical for your application, it would be advisable to confirm with the manufacturer whether custom configurations or additional models are available.