FDA.reportPublic FDA data

CoMoveIT

Primary DI
05430002911007
Brand
CoMoveIT
Company
Comoveit
Model
Smart ECU
Device description
Adaptive electronics control unit.
Published
2025-01-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNNComponents, Wheelchair

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNNComponents, WheelchairPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05430002911007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05430002911007054300029110075430002911007

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair steering/control unitAn electronic device used by a wheelchair occupant or attendant to guide the wheelchair's movements and direction of travel. This device may be operated by the occupant's hand, mouth, or signals provided by other means, or by the attendant as required. This device will include the installation package.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+32477880175info@comoveit.com

Regulatory Flags#

DUNS number
372677110
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
05430002911052CoMoveITECU Mount For Permobil2025-01-13
05430002911069CoMoveITHeadset Mounting Clamp2025-01-13
05430002911076CoMoveITECU Mount For Ottobock2025-01-13
05430002911083CoMoveITTilt Mechanism2025-01-13
05430002911014CoMoveITSmart H32025-01-13
05430002911038CoMoveITSmart F2025-01-13
05430002911045CoMoveITSmart dF2025-01-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06972077026464EvermedXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-07
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06972077026488EvermedXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-07
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06972077026266EmeraldXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-06
06972077026273EmeraldXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-06
06972077026327EvermedXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-06
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06972077026341EvermedXIAMEN TAFT MEDICAL CO.,LTD.KNN2026-05-06
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