Device
Mid-wheel drive powered wheelchair intended to provide mobility assistance to individuals with mobility impairments. Device may be configured with powered seating functions includi...
Manufacturer
Velox Manufacturing Inc
Model: MPC DI: 00860015909206 Status: New MRI: MR Unsafe Single-use: No Rx: Yes OTC: No
First Published: 2026-05-28 Current Version: 2026-06-05
Description
Mid-wheel drive powered wheelchair intended to provide mobility assistance to individuals with mobility impairments. Device may be configured with powered seating functions including tilt, recline, elevating legrests, and seat elevation
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 86b5e5e8-08d6-4017-a09c-368207529644
Distribution Status: In Commercial Distribution
DUNS Number: 203732131
Device Count: 1
DM Exempt: No
Premarket Exempt: No
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: No
Serial Number Tracked: Yes
Manufacturing Date Tracked: Yes
Expiration Date Tracked: No
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 00860015909206
Type: Primary
Issuing Agency: GS1
GMDN
Code: 41875
Name: Electric-motor-driven wheelchair, occupant-controlled
Definition:
An electrically-powered wheeled personal mobility device with a seat designed to enable a non-bariatric person with a disability, or without the full capacity to walk, to self-mobilize using power from an electric motor(s). It includes controls (typically joystick) to allow the occupant electronic control of speed/direction; it is not designed with a foot platform and handlebars (i.e., not a mobility scooter).
FDA Product Codes
ITI
Wheelchair, Powered
Premarket Submissions
Submission Number: K231315
Supplement Number: 000