Identity
- Trade Name
- Pal EUDAMEDLeckey PAL FDA UDI
- Generic Name
- General-purpose stool/chair FDA UDI
- Device Name
- Seating EUDAMEDThe PAL Seating System gives improved stability which helps reduce fatigue and allows the child longer periods of concentration and fine motor activity. FDA UDI
- Model / Reference
- 135 EUDAMEDPAL FDA UDI
- Description
- The PAL Seating System gives improved stability which helps reduce fatigue and allows the child longer periods of concentration and fine motor activity. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05059804135000 EUDAMEDFDA UDI
- Basic UDI-DI
- 05059804101SeatingCK EUDAMED
- Direct Marketing DI
- 05059804135000 EUDAMED
- FDA Product Code
- ILS FDA UDI
- EMDN Code
- Y180999 CHAIRS / POSTURE SYSTEMS / SEAT POSITIONING AIDS - OTHER EUDAMED
- GMDN Term
- General-purpose stool/chair FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.5050 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
Pal 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 | 05059804101SeatingCK | 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 85c85a77-dccb-4377-9ed9-34342ef0b522 61 fields · synced Jul 11, 2026
- FDA UDI c76f0333-176e-4ff7-8836-34c092a18880 33 fields · synced May 22, 2026