FDA.report

CoMoveIT

Primary DI
05430002911076
Brand
CoMoveIT
Company
Comoveit
Model
ECU Mount For Ottobock
Device description
ECU mount CoMoveIT Smart for Ottobock powered wheelchairs.
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

Related Records

Contact Domains

Product Codes

CodeName
KNNComponents, Wheelchair

Product Code Classifications

CodeDeviceSpecialtyClass
KNNComponents, WheelchairPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05430002911076PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05430002911076054300029110765430002911076

GMDN Terms

TermDefinition
Wheelchair bracketA device, typically a metal rack, that is attached to a wheelchair and used to mount accessories for wheelchair customization or to adapt to new requirements.

Sterilization Methods

Method

Contacts

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
true
Serial number
false
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 DIBrandModelCatalogPublished
05430002911007CoMoveITSmart ECU2025-01-13
05430002911014CoMoveITSmart H32025-01-13
05430002911038CoMoveITSmart F2025-01-13
05430002911045CoMoveITSmart dF2025-01-13
05430002911052CoMoveITECU Mount For Permobil2025-01-13
05430002911069CoMoveITHeadset Mounting Clamp2025-01-13
05430002911083CoMoveITTilt Mechanism2025-01-13

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