Identity
- Trade Name
- Pronestander EUDAMEDLeckey Pronestander FDA UDI
- Generic Name
- Manual stander FDA UDI
- Device Name
- Standing EUDAMEDThe Leckey Pronestander is a robust stander with a choice of five prone positions from 45° to 85°. In addition to the prone angle adjustment, the stander covers a large growth range and has adjustable chest, hip and knee supports, to ensure that it meets a large range of clinical needs. FDA UDI
- Model / Reference
- LPS EUDAMEDPronestander FDA UDI
- Description
- The Leckey Pronestander is a robust stander with a choice of five prone positions from 45° to 85°. In addition to the prone angle adjustment, the stander covers a large growth range and has adjustable chest, hip and knee supports, to ensure that it meets a large range of clinical needs. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05059804300002 EUDAMEDFDA UDI
- Basic UDI-DI
- 05059804102StandingEW EUDAMED
- Direct Marketing DI
- 05059804300002 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
Pronestander by James Leckey Design 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 | K944307 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 05059804102StandingEW | Class I | Active |
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Manufacturer
- Manufacturer
- James Leckey Design Ltd
- EUDAMED SRN
- XI-MF-000003572
- FDA Applicant
- James Leckey Design
Sources (3)
- EUDAMED f3e04a4b-b21f-43a6-ba76-5baecd6a54df 85 fields · synced Jun 19, 2026
- FDA UDI b1ae79c2-9e02-47c5-a3fc-d164f22c941b 33 fields · synced May 30, 2026
- FDA 510(k) K944307 1 fields · synced May 18, 2026