FDA.reportPublic FDA data

Velox

Primary DI
00860015909206
Brand
Velox
Company
Velox Manufacturing Inc
Model
MPC
Device 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
Published
2026-05-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
ITIWheelchair, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITIWheelchair, PoweredPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231315000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231315000Velox Power ChairVelox Manufacturing, Inc.2024-01-12ITI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860015909206PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860015909206008600159092068600159092060860015909206

GMDN Terms#

Term, Definition table
TermDefinition
Electric-motor-driven wheelchair, occupant-controlledAn 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).

Contacts#

Phone, Email table
PhoneEmail
604-209-5367sales@poweredbyvelox.com

Regulatory Flags#

DUNS number
203732131
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974842140160RobooterShanghai Bangbang Robotics Co.,Ltd.ITI2026-07-24
06974842140177RobooterShanghai Bangbang Robotics Co.,Ltd.ITI2026-07-24
06974842140504Robooter E60Shanghai Bangbang Robotics Co.,Ltd.ITI2026-07-24
06974842140566RobooterShanghai Bangbang Robotics Co.,Ltd.ITI2026-07-24
06974842140580Robooter E60Shanghai Bangbang Robotics Co.,Ltd.ITI2026-07-24
06974842140641Robooter E60Shanghai Bangbang Robotics Co.,Ltd.ITI2026-07-24
06974842140665Robooter E60Shanghai Bangbang Robotics Co.,Ltd.ITI2026-07-24
06974842140726Robooter E60Shanghai Bangbang Robotics Co.,Ltd.ITI2026-07-24
06974842140740Robooter E60Shanghai Bangbang Robotics Co.,Ltd.ITI2026-07-24
06974842142102RobooterShanghai Bangbang Robotics Co.,Ltd.ITI2026-07-24
06974842142119RobooterShanghai Bangbang Robotics Co.,Ltd.ITI2026-07-24
06974842142126RobooterShanghai Bangbang Robotics Co.,Ltd.ITI2026-07-24
06974842142140RobooterShanghai Bangbang Robotics Co.,Ltd.ITI2026-07-24
06974842142072Electric WheelchairShanghai Bangbang Robotics Co.,Ltd.ITI2026-07-23
06974842142089Electric WheelchairShanghai Bangbang Robotics Co.,Ltd.ITI2026-07-23
06974842142096Electric WheelchairShanghai Bangbang Robotics Co.,Ltd.ITI2026-07-23
06974842142133RobooterShanghai Bangbang Robotics Co.,Ltd.ITI2026-07-23
06974842141693Electric WheelchairShanghai Bangbang Robotics Co.,Ltd.ITI2026-07-07
06974665661095EldHilfeYongkang Youha Electric Appliance Co.,LtdITI2026-06-24
06977027831099CHINFREANZhejiang Nysin Medical Co.,LtdITI2026-06-23
06973175531430MOGOAnhui JBH Medical Apparatus Co., Ltd.ITI2026-05-30
06973134773017sliverfoxSilverfox Corporation LimitedITI2026-05-27
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