Ability Drive
by TOLT Technologies LLC United States EUDAMEDGUDID
Ref ADT
Product code KNOEMDN Y122403
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number++G187ADTT2 | Date26 Dec 2023 | StatusActive |
| United States | GUDID listing GUDID | NumberG187ADT0 | Date6 Jan 2022 | StatusIn distribution |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Ability Drive EUDAMEDTolt Technologies LLC GUDID
- Generic Name
- Wheelchair steering/control unit
- Model / Ref / Catalog
- ADT
- Primary DI / UDI-DI
- G187ADT0
- Basic UDI-DI
- ++G187ADTT2
- Secondary DI
- 08600108085040
- Direct Marketing DI
- G187ADT0
- FDA Product Code
- KNO
- EMDN Code
- Y122403 Wheelchair footrests, supports and controls
- GMDN Term
- Wheelchair steering/control unit
- Device Class
- Class I
- Regulation Number
- 890.3910
- Market of Registration
- Denmark
- Commercial Distribution
- In Commercial Distribution
Manufacturer details
- EUDAMED SRN
- US-MF-000039082
- Authorised representative
- A/S Aabentoft DK-AR-000036033
Properties & raw data
Show properties, registry sources and raw records
Other properties (22)
- Sterile: No
- Single Use: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Lot / Batch Number: No
- Expiration Date: No
- Manufacturing Date: No
Sources (2)
- EUDAMED 51c965bd-ccac-4aec-b1c2-b660fc124d40
- FDA UDI 29c6ac9b-d03d-4ee6-a9ef-d2d59056850a