EZER 002

Organization name

J58 Holding B.V.

SRN

NL-MF-000046315

Manufacturer status

Active

12 warnings recorded — scroll inside the panel to see all entries.

• CW999

  Warning: Ensure brakes are applied when stability is critical (standing, transfers, parking); inadequate braking or tyre pressure may reduce braking efficiency.
• CW999

  Warning: Keep clothing and loose items clear of wheels and moving parts; do not stand on the footplate when entering or exiting.
• CW999

  Warning: Children must not stand or play on the wheelchair.
• CW999

  Warning: Do not lift the wheelchair by removable parts; never disassemble or modify the frame structure — unauthorized repairs or modifications void the warranty and may cause injury.
• CW999

  Warning: During transport and storage, protect the release mechanism from pressure or accidental activation; ensure mechanism cannot be accidentally activated in a vehicle.
• CW010

  EUDAMED did not publish a description for this code.
• CW999

  Warning: Consult a doctor or physical therapist before using the standing function; not suitable without clinical assessment for users with strong spasms, cramps, involuntary movements, strong contractures, osteoporosis, amputation, or any condition that affects natural centre of gravity.
• CW999

  Warning: Always secure knee support and chest strap before activating the standing mechanism; never attempt to stand without these restraints.
• CW999

  Contra‑indication: Do not use the EZER with an unconscious person or by more than one user at a time.
• CW011

  The standing function must only be used on firm, level ground; activating the standing mechanism on inclines, uneven or unstable surfaces increases tipping risk.
• CW999

  Warning: Do not exceed maximum user weight of 120 kg; overloading can cause damage, malfunction, and safety hazards.
• CW999

  Warning: Do not use the wheelchair as a vehicle seat; users must be transferred to a vehicle seat for transport — the EZER is not approved for use as a vehicle restraint.

Primary placement in Netherlands; available across 32 countries total.

Trade name

not provided

UDI-DI code

07649994843021

Basic UDI-DI

7649994843002JD

Reference / catalog number

EZER 002

Issuing entity

GS1

Risk category

Class I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

The EZER 002 Mechanical Standing Wheelchair is a product which changes people’s position from seating to standing and standing to seating.

Additional information URL

https://www.j58.eu/

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Y122106REAR SELF-PROPELLED WHEELCHAIRS

This device is not currently linked to any other device.