Empluse EISP9

GUDID 00016958059366

The R20 device is intended to be used by the assistant of a wheelchair user to aid in the propulsion of the chair and user over interior and exterior terrain.

SUNRISE MEDICAL (US) LLC

Wheelchair electric-motor-driven propulsion system

• Primary Device ID: 00016958059366
• NIH Device Record Key: a7be082f-4487-418f-a312-3858c57e931f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Empluse
• Version Model Number: R20
• Catalog Number: EISP9
• Company DUNS: 962525056
• Company Name: SUNRISE MEDICAL (US) LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00016958059366 [Primary]

FDA Product Code

• KNO: Accessories, Wheelchair

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-01
• Device Publish Date: 2024-07-24

On-Brand Devices [Empluse]

• 00016958059366: The R20 device is intended to be used by the assistant of a wheelchair user to aid in the propul
• 00016958059380: A wheelchair power assist device. It uses a lithium battery to power a single front wheel, which