Identity
- Trade Name
- Horizon Size 3 EUDAMEDLeckey Horizon 3 FDA UDI
- Generic Name
- Manual stander FDA UDI
- Device Name
- Standing EUDAMEDThe individually adjustable chest, hip and knee pads along with the footplates, provide unsurpassed levels of adjustability for proximal positioning - making the Horizon ideal for more complex users or adults who have not benefitted from standing therapy for some time. The Horizon range enables the safe and easy transfer of users using either mobile or tracking hoists, with the size 3 having been designed with the larger teen or adult client in mind- this has a maximum weight limit of 100kg (220lbs) as well as wider hip pad and chest lateral distances. FDA UDI
- Model / Reference
- LHZ/3 EUDAMEDHorizon Size 3 FDA UDI
- Description
- The individually adjustable chest, hip and knee pads along with the footplates, provide unsurpassed levels of adjustability for proximal positioning - making the Horizon ideal for more complex users or adults who have not benefitted from standing therapy for some time. The Horizon range enables the safe and easy transfer of users using either mobile or tracking hoists, with the size 3 having been designed with the larger teen or adult client in mind- this has a maximum weight limit of 100kg (220lbs) as well as wider hip pad and chest lateral distances. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05059804101036 EUDAMEDFDA UDI
- Basic UDI-DI
- 05059804102StandingEW EUDAMED
- Direct Marketing DI
- 05059804101036 EUDAMED
- FDA Product Code
- INM FDA UDI
- EMDN Code
- Y050202 STANDING FRAMES EUDAMED
- GMDN Term
- Manual stander FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3100 FDA UDI
- Market of Registration
- Northern Ireland 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Horizon Size 3 by James Leckey Design Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 05059804102StandingEW | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- James Leckey Design Ltd
- EUDAMED SRN
- XI-MF-000003572
Sources (2)
- EUDAMED df4cafa5-6b16-4a09-937b-ac0e783b36e1 61 fields · synced Jun 18, 2026
- FDA UDI c6cacdad-397c-4b5b-9d64-9ed908a189e8 33 fields · synced May 24, 2026