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510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

Electric Wheelchair (Rollz Motion Electric 2M)

Manufacturer

Rollz International bv

Date Cleared

2025-11-07

(234 days)

Product Code

Regulation Number

Type

Panel

Physical Medicine

Age Range

All

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

The Electric Wheelchair is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

Device Description

Not Found

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