FDA UDI
In Commercial Distribution
🇺🇸 United States
CoMoveIT
DI: 05430002911007
·
Model: Smart ECU
·
Comoveit
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CoMoveIT
- Primary DI
- 05430002911007
- Version / Model
- Smart ECU
- Company Name
- Comoveit
- Labeler DUNS
- 372677110
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-13
- Public Version
- 1
- Public Version Date
- 2025-01-21
- Public Version Status
- New
- Public Device Record Key
- 0270606b-e1de-4cd3-ba55-f966a6e01c3a
Device Description
Adaptive electronics control unit.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KNN | Components, Wheelchair | Physical Medicine | 890.3920 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 30018 | Wheelchair steering/control unit | An 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05430002911007 | GS1 |
Customer Contacts
- Phone
- +32477880175
- [email protected]