FDA.reportPublic FDA data

Motion composites

Primary DI
00811774000079
Brand
Motion composites
Company
Motion Composites Inc
Model
Apex A
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
K161425000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161425000APEX Manual WheelchairMotion Composites2016-12-05IOR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811774000079PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811774000079008117740000798117740000790811774000079

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair, attendant/occupant-driven, rear-wheels-operated, non-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 cannot be folded or readily dismantled 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@motioncomposites.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
00811774000031Motion compositesHelio C22022-09-24
00811774000062Motion compositesHelio A62022-09-24
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
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M368G1002811GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31