ComfyGO IQ-9000

GUDID 00810203610407

Electric wheelchair with foldable frame, airline-approved lithium battery, and joystick controller. Marketed under the MAJESTIC brand.

ComfyGO, Inc

Electric-motor-driven wheelchair, occupant-controlled

• Primary Device ID: 00810203610407
• NIH Device Record Key: facd8235-96ae-4a19-9911-2c76806446de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ComfyGO
• Version Model Number: IQ-9000
• Catalog Number: IQ-9000
• 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
• Phone: +18447555055
• Email: info@comfygo.us

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep in dry environment. Avoid water exposure. Disconnect battery for long-term storage.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep in dry environment. Avoid water exposure. Disconnect battery for long-term storage.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep in dry environment. Avoid water exposure. Disconnect battery for long-term storage.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep in dry environment. Avoid water exposure. Disconnect battery for long-term storage.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep in dry environment. Avoid water exposure. Disconnect battery for long-term storage.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep in dry environment. Avoid water exposure. Disconnect battery for long-term storage.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep in dry environment. Avoid water exposure. Disconnect battery for long-term storage.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep in dry environment. Avoid water exposure. Disconnect battery for long-term storage.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep in dry environment. Avoid water exposure. Disconnect battery for long-term storage.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep in dry environment. Avoid water exposure. Disconnect battery for long-term storage.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep in dry environment. Avoid water exposure. Disconnect battery for long-term storage.
• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Keep in dry environment. Avoid water exposure. Disconnect battery for long-term storage.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810203610407 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192739

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: 2026-01-15
• Device Publish Date: 2026-01-07

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
• 00810203610827: Electric wheelchair with foldable frame, airline-approved lithium battery, and joystick controll
• 00810203610797: Manual wheelchair with foldable frame, airline-approved, Marketed under the ComfyGO brand.
• 00810203610568: Electric wheelchair with foldable frame, airline-approved lithium battery, and joystick controll
• 00810203610407: Electric wheelchair with foldable frame, airline-approved lithium battery, and joystick controll