FDA.reportPublic FDA data

RoughRider

Primary DI
00860009406056
Brand
RoughRider
Company
Roughrider America LLC
Model
RoughRider
Device description
manually propelled wheelchair
Published
2023-02-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
IORWheelchair, Mechanical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IORWheelchair, MechanicalPhysical Medicine1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103212000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103212000ROUGHRIDERWhirlwind Wheelchair International2011-01-03IOR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860009406056PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009406056008600094060568600094060560860009406056

GMDN Terms#

Term, Definition table
TermDefinition
Push-rim manual wheelchair, non-bariatricA non-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 by pushing specially designed rims on the wheels while seated. It is designed with a pair of larger wheels with push-rims attached whereby the occupant propels the device by rotating both wheels; it typically includes rear-fitted handles designed for optional pushing by an attendant.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
5105481333marc@roughrideramerica.com

Regulatory Flags#

DUNS number
052942916
Device count
1
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860003056608RoughRider Aurora2023-03-01
00860003056615RoughRider Aurora2023-03-01
00860003056622RoughRider Aurora2023-03-01
00860003056639RoughRider Aurora2023-03-01
00860003056646RoughRider Aurora2023-03-01
00860003056653RoughRider Aurora2023-03-01
00860003056660RoughRider Aurora2023-03-01
00860003056677RoughRider Aurora2023-03-01
00860009406001RoughRiderRoughRider2023-02-17
00860009406018RoughRiderRoughRider2023-02-17
00860009406025RoughRiderRoughRider2023-02-17
00860009406032RoughRiderRoughRider2023-02-17
00860009406049RoughRiderRoughRider2023-02-17
00860009406063RoughRiderRoughRider2023-02-17
00860009406070RoughRiderRoughRider2023-02-17
00860009406087RoughRiderRoughRider2023-02-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975996304019Manual wheelchairGuangdong Xiangyuanheng Medical Technology Co., Ltd.IOR2026-05-30
06975996304026Manual wheelchairGuangdong Xiangyuanheng Medical Technology Co., Ltd.IOR2026-05-30
06975996304033Manual wheelchairGuangdong Xiangyuanheng Medical Technology Co., Ltd.IOR2026-05-30
06975996304040Manual wheelchairGuangdong Xiangyuanheng Medical Technology Co., Ltd.IOR2026-05-30
06975996304057Manual wheelchairGuangdong Xiangyuanheng Medical Technology Co., Ltd.IOR2026-05-30
00810178884865Vive MobilityVIVE HEALTH LLCIOR2026-04-26
00810178885008Vive MobilityVIVE HEALTH LLCIOR2026-04-26
00810178885961Vive MobilityVIVE HEALTH LLCIOR2026-04-26
00810178885978Vive MobilityVIVE HEALTH LLCIOR2026-04-26
M36867262250R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
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