XSTO

GUDID 06975052650128

Powered wheelchair (mobility robot), Model: M4U; Rx

XSTO CO., LTD.

Electric-motor-driven wheelchair, occupant-controlled

• Primary Device ID: 06975052650128
• NIH Device Record Key: abe79f08-f4b6-48b7-b2d4-d158f06135e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XSTO
• Version Model Number: M4U
• Company DUNS: 544574579
• Company Name: XSTO CO., LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06975052650128 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242358

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: 2025-06-24
• Device Publish Date: 2025-06-16

On-Brand Devices [XSTO]

• 06975052650128: Powered wheelchair (mobility robot), Model: M4U; Rx
• 06975052650111: Powered wheelchair (mobility robot), Model: M4U; OTC
• 06975052650104: Powered wheelchair (mobility robot), Model: M4; Rx
• 06975052650098: Powered wheelchair (mobility robot), Model: M4; OTC