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
Rx
false
OTC
false
Sterile
false
Single use
false

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05430002911014CoMoveITSmart H32025-01-13
05430002911038CoMoveITSmart F2025-01-13
05430002911045CoMoveITSmart dF2025-01-13
05430002911052CoMoveITECU Mount For Permobil2025-01-13
05430002911069CoMoveITHeadset Mounting Clamp2025-01-13
05430002911076CoMoveITECU Mount For Ottobock2025-01-13
05430002911083CoMoveITTilt Mechanism2025-01-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09420082699434Spex SeatingSPEX LIMITEDKNN2026-02-20
00841447116424The Aftermarket Group (TAG) Schwalbe Right Run Wheelchair TireINVACARE CORPORATIONKNN2026-02-05
05407008321246mo-vismo-VisKNN2026-01-01
00815067013548ProbasicsCOMPASS HEALTH BRANDS CORP.KNN2025-08-13
00815067013555ProbasicsCOMPASS HEALTH BRANDS CORP.KNN2025-08-13
00815067013562ProbasicsCOMPASS HEALTH BRANDS CORP.KNN2025-08-13
00815067013579ProbasicsCOMPASS HEALTH BRANDS CORP.KNN2025-08-13
04714379299328MERITSMERITS HEALTH PRODUCTS CO., LTD.KNN2025-08-08
04714379299335MERITSMERITS HEALTH PRODUCTS CO., LTD.KNN2025-08-08
04714379299342MERITSMERITS HEALTH PRODUCTS CO., LTD.KNN2025-08-08
04714379299359MERITSMERITS HEALTH PRODUCTS CO., LTD.KNN2025-08-08
10197344158393MEDLINEMEDLINE INDUSTRIES, INC.KNN2025-07-28
00815067013074ProbasicsCOMPASS HEALTH BRANDS CORP.KNN2025-07-21
00815067013081ProbasicsCOMPASS HEALTH BRANDS CORP.KNN2025-07-21
10197344155279MEDLINEMEDLINE INDUSTRIES, INC.KNN2025-06-27
05407008321130mo-Vismo-VisKNN2025-03-27
05407008321147mo-Vismo-VisKNN2025-03-27
05407008321154mo-Vismo-VisKNN2025-03-27
05407008321161mo-Vismo-VisKNN2025-03-27
05407008321178mo-Vismo-VisKNN2025-03-27
05407008321185mo-Vismo-VisKNN2025-03-27
05407008321116mo-vismo-VisKNN2025-03-21
05407008321192mo-Vismo-VisKNN2025-03-21
05407008321208mo-vismo-VisKNN2025-03-21
05407008321215mo-vismo-VisKNN2025-03-21
09420051706217Spex LimitedSPEX LIMITEDKNN2025-03-18
09420051706798Spex LimitedSPEX LIMITEDKNN2025-03-18
09420051709881Spex LimitedSPEX LIMITEDKNN2025-03-18
09420051709911Spex LimitedSPEX LIMITEDKNN2025-03-18
09420051709935Spex LimitedSPEX LIMITEDKNN2025-03-18