WHILL, Inc. 32-00022-J-02-2024-02-15

GUDID 04570072300026

The intended use of the WHILL Model C2 powered wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair. This is for 16-inch.

WHILL, INC.

Electric-motor-driven wheelchair, occupant-controlled

• Primary Device ID: 04570072300026
• NIH Device Record Key: 1cac3190-016c-4812-8378-505e6208403f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WHILL, Inc.
• Version Model Number: Model C2
• Catalog Number: 32-00022-J-02-2024-02-15
• Company DUNS: 691746455
• Company Name: WHILL, INC.
• 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: 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	04570072300026 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213383

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: 2024-09-10
• Device Publish Date: 2024-09-02

On-Brand Devices [WHILL, Inc.]

• 04570072301832: The intended use of the WHILL Model F powered wheelchair is to provide outdoor and indoor mobili
• 04570072300033: The intended use of the WHILL Model C2 powered wheelchair is to provide outdoor and indoor mobil
• 04570072300026: The intended use of the WHILL Model C2 powered wheelchair is to provide outdoor and indoor mobil