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Focus CR
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref FOCUSModel Manual Wheelchairs510(k) K200583
Identity
- Trade Name
- Focus CR EUDAMEDFDA UDI
- Generic Name
- Push-rim manual wheelchair, non-bariatric FDA UDI
- Device Name
- FOCUS MANUAL WHEELCHAIR FDA UDI
- Model / Reference
- Manual Wheelchairs EUDAMEDFOCUS EUDAMEDCR FDA UDI
- Description
- FOCUS MANUAL WHEELCHAIR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850013379118 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850013379MANUALWN EUDAMED
- 510(k) Number
- K200583 FDA UDI
- FDA Product Code
- IOR FDA UDI
- EMDN Code
- Y122103 PUSH WHEELCHAIRS EUDAMED
- GMDN Term
- Push-rim manual wheelchair, non-bariatric FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3850 FDA UDI
- Market of Registration
- Sweden 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
Yes
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
Yes
FDA UDI
Focus CR by Ki Mobility, Llc — 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 | K200583 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 0850013379MANUALWN | Class I | Active |
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Manufacturer
- Manufacturer
- Ki Mobility LLC
- EUDAMED SRN
- US-MF-000012633
- FDA Applicant
- Ki Mobility, LLC
- Authorised Representative
- Etac Supply Center AB SE-AR-000001601
Sources (3)
- EUDAMED b5dca656-ee0b-4120-9446-d87e7adca16f 85 fields · synced Jun 18, 2026
- FDA UDI a3f33afd-d984-4d74-80c9-7c58951ee24c 35 fields · synced May 30, 2026
- FDA 510(k) K200583 1 fields · synced Jun 9, 2026