FDA.reportPublic FDA data

Motion composites

Primary DI
00811774000031
Brand
Motion composites
Company
Motion Composites Inc
Model
Helio C2
Device description
wheelchair mechanical
Published
2022-09-24
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
K120628000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120628000HELIOMotion Composites2012-12-19IOR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811774000031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811774000031008117740000318117740000310811774000031

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsibleA wheeled personal mobility device that incorporates a seat-support system for a person with a disability or a person without the full capacity to walk (not bariatric) designed to be manually propelled by the user while seated in the device or by an attendant. The occupant moves the device by rotating both rear wheels. An attendant moves the device by pushing or pulling handles on the device. The device may be disassembled or folded for transport.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Fragile handle with care

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-866-650-6555info@montioncomposites.com

Regulatory Flags#

DUNS number
243913550
Device count
1
DM exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811774000017Motion compositesHelio A72022-09-24
00811774000024Motion compositesVeloce2022-09-24
00811774000062Motion compositesHelio A62022-09-24
00811774000079Motion compositesApex A2022-09-24
00811774000086Motion compositesApex C2022-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
M36867282030R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867282050R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867282230R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867282250R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867302030R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867302050R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867302230R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
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M36867322030R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
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M36867322250R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867342030R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867342050R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867342230R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867342250R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
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M36868282050R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
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M36868302050R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36868302250R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36868322250R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36868342050R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36868342250R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M368G1002811GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31