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CTM Mobility Scooter
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref HS-268, HS-268M, Scorpius, Scorpius A, Li-Tech Velo, eFlexxModel HS-268510(k) K192885
Identity
- Trade Name
- CTM Mobility Scooter EUDAMEDCTM FDA UDI
- Generic Name
- Assistive scooter, electric-motor-driven FDA UDI
- Device Name
- Mobility Scooter EUDAMEDFolding Scooter / Invacare Scorpius 4 Wheel Scooter, Red, 5 mph FDA UDI
- Model / Reference
- HS-268 EUDAMEDFDA UDIHS-268, HS-268M, Scorpius, Scorpius A, Li-Tech Velo, eFlexx EUDAMED
- Description
- Folding Scooter / Invacare Scorpius 4 Wheel Scooter, Red, 5 mph FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850017490000 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850017490HS-268M5 EUDAMED
- FDA Product Code
- INI FDA UDI
- EMDN Code
- Y122124 ELECTRIC SCOOTERS EUDAMED
- GMDN Term
- Assistive scooter, electric-motor-driven FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 890.3800 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
CTM Mobility Scooter by Chien Ti Enterprise Co., Ltd. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K192885 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 0850017490HS-268M5 | Class I | Active |
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Manufacturer
- Manufacturer
- Chien Ti Enterprise Co., Ltd.
- EUDAMED SRN
- TW-MF-000001535
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (4)
- EUDAMED d9d923a7-3dac-45ef-b74d-5b98c3e45551 85 fields · synced Jul 30, 2026
- FDA UDI 3f22af4c-d55b-4f6c-b32b-ad7f2bd5e13d 33 fields · synced May 30, 2026
- EUDAMED d9d923a7-3dac-45ef-b74d-5b98c3e45551-1 61 fields · synced Jun 9, 2026
- FDA 510(k) K192885 1 fields · synced May 18, 2026