Empluse EISP11

GUDID 00016958059380

A wheelchair power assist device. It uses a lithium battery to power a single front wheel, which the handlebar can steer. The device is attached to the wheelchair by a hook-and-latched subframe and a permanently installed wheelchair frame clamp.

SUNRISE MEDICAL (US) LLC

Wheelchair electric-motor-driven propulsion system

• Primary Device ID: 00016958059380
• NIH Device Record Key: 3e0db3a1-40f6-45fb-be03-751ba438c6e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Empluse
• Version Model Number: F35
• Catalog Number: EISP11
• Company DUNS: 962525056
• Company Name: SUNRISE MEDICAL (US) LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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	00016958059380 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220213

FDA Product Code

• ITI: Wheelchair, Powered

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: 2025-04-29
• Device Publish Date: 2025-04-21

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