ComfyGO G-5

GUDID 00810203610728

This device is a powered mobility aid intended to assist individuals with mobility difficulties. It features an electric motor system, a foldable and portable frame, and is designed for ease of use. The device includes basic user controls for direction and speed, that provide support and safety for the user. It is suitable for use in various environments, including both indoor and outdoor settings, and is designed to be durable, user-friendly, and low-maintenance.

ComfyGO, Inc

Electric-motor-driven wheelchair, occupant-controlled

• Primary Device ID: 00810203610728
• NIH Device Record Key: 0c7e03d1-ab9a-48c6-adbb-ac0ecbfe4809
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ComfyGO
• Version Model Number: G-5
• Catalog Number: G-5
• Company DUNS: 094882026
• Company Name: ComfyGO, Inc
• 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: true
• 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

Customer Support Contacts

• Phone: +18447555055
• Email: info@comfygo.us
• Phone: +18447555055
• Email: info@comfygo.us
• Phone: +18447555055
• Email: info@comfygo.us
• Phone: +18447555055
• Email: info@comfygo.us
• Phone: +18447555055
• Email: info@comfygo.us
• Phone: +18447555055
• Email: info@comfygo.us
• Phone: +18447555055
• Email: info@comfygo.us
• Phone: +18447555055
• Email: info@comfygo.us
• Phone: +18447555055
• Email: info@comfygo.us
• Phone: +18447555055
• Email: info@comfygo.us
• Phone: +18447555055
• Email: info@comfygo.us
• Phone: +18447555055
• Email: info@comfygo.us

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place between 10–40°C, avoid prolonged exposure to direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place between 10–40°C, avoid prolonged exposure to direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place between 10–40°C, avoid prolonged exposure to direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place between 10–40°C, avoid prolonged exposure to direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place between 10–40°C, avoid prolonged exposure to direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place between 10–40°C, avoid prolonged exposure to direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place between 10–40°C, avoid prolonged exposure to direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place between 10–40°C, avoid prolonged exposure to direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place between 10–40°C, avoid prolonged exposure to direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place between 10–40°C, avoid prolonged exposure to direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place between 10–40°C, avoid prolonged exposure to direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place between 10–40°C, avoid prolonged exposure to direct sunlight.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810203610728 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240563

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: 2025-09-19
• Device Publish Date: 2025-09-11

On-Brand Devices [ComfyGO]

• 00810203610018: Lightweight carbon fiber electric wheelchair with foldable frame, airline-approved lithium batte
• 00810203610728: This device is a powered mobility aid intended to assist individuals with mobility difficulties.
• 00810203610773: Electric Wheelchair