FDA.reportPublic FDA data

Klaxon

Primary DI
00840363369082
Brand
Klaxon
Company
KI MOBILITY, LLC
Model
Twist
Catalog number
123882
Device description
Battery powered power add-on designed to provide power assistance to manual wheelchair users. It is designed to augment the manual propulsion provided by the user, reducing the effort required by the user to propel the wheelchair.
Published
2025-06-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ITIWheelchair, powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITIWheelchair, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840363369082PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840363369082008403633690828403633690820840363369082

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair electric-motor-driven propulsion systemAn assembly of devices added/retrofitted to a manual wheelchair (occupant or attendant driven) to provide the occupant with an electrical-powered drive mechanism, including the energy source (batteries) to achieve this. The steering, control, and brake systems will typically be included. This retrofitted accessory may alter the wheel configuration of the wheelchair in order to provide the powered propulsion (e.g., from a conventional four-wheeled to a tricycle configuration or additional propulsion wheels at the rear of the wheelchair).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity60 Percent (%) Relative Humidity
Storage Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)981-1540sales@kimobility.com

Regulatory Flags#

DUNS number
609305656
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840363369624AxiomAxiom GXG1719IC2025-12-02
00840363372259AxiomAxiom PXPPXP0809BLKIC2025-12-05
00840363372280AxiomAxiom PXPPXP0909BLKIC2025-12-05
00840363372303AxiomAxiom PXPPXP1008BLKIC2025-12-05
00840363372327AxiomAxiom PXPPXP1010BLKIC2025-12-05
00840363372358AxiomAxiom PXPPXP1013BLKIC2025-12-05
00840363372365AxiomAxiom PXPPXP1014BLKIC2025-12-05
00840363372389AxiomAxiom PXPPXP1110BLKIC2025-12-05
00840363372396AxiomAxiom PXPPXP1111BLKIC2025-12-05
00840363372402AxiomAxiom PXPPXP1112BLKIC2025-12-05
00840363372419AxiomAxiom PXPPXP1113BLKIC2025-12-05
00840363372440AxiomAxiom PXPPXP1211BLKIC2025-12-05
00840363372464AxiomAxiom PXPPXP1213BLKIC2025-12-05
00840363372471AxiomAxiom PXPPXP1214BLKIC2025-12-05
00840363372501AxiomAxiom PXPPXP1310BLKIC2025-12-05
00840363372518AxiomAxiom PXPPXP1311BLKIC2025-12-05
00840363372525AxiomAxiom PXPPXP1312BLKIC2025-12-05
00840363372532AxiomAxiom PXPPXP1313BLKIC2025-12-05
00840363372549AxiomAxiom PXPPXP1314BLKIC2025-12-05
00840363372563AxiomAxiom PXPPXP1316BLKIC2025-12-05

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Primary DI, Brand, Company table
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