gudid Primary ID: R90

Empulse (UDI R90)

Manufactured by SUNRISE MEDICAL (US) LLC

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The Empulse (Model/Catalog Number: R90) is a medical device manufactured by SUNRISE MEDICAL (US) LLC. This product is indexed under FDA Product Code / Category Classification ITI within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: R90
Product Code / EMDN: ITI
Device Name: The R90 is intended to be used to provide power assistance to manual wheelchair users. It is designed to augment the manual propulsion provided by the user, reducing the effort required by the user to propel the wheelchair.
Database Sync Date: 2026-08-09 09:00:34

Full Regulatory Attributes

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{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

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Frequently Asked Questions

Who is the primary manufacturer of Empulse?

The registered manufacturer of record for Empulse is SUNRISE MEDICAL (US) LLC.

What is the Primary UDI-DI identifier for Empulse?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is R90.

What classification code is assigned to this device?

This device is registered under product classification code ITI.

Similar Classification Devices (ITI)

Other Devices by SUNRISE MEDICAL (US) LLC

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