Identity
- Trade Name
- Mygo Stander EUDAMEDLeckey MyGo Stander FDA UDI
- Generic Name
- Manual stander/exerciser FDA UDI
- Device Name
- Standing EUDAMEDThe Leckey MyGo Stander delivers truly excellent prone, supine and upright positioning for children with moderate to complex needs. FDA UDI
- Model / Reference
- 143 EUDAMEDMyGo Stander FDA UDI
- Description
- The Leckey MyGo Stander delivers truly excellent prone, supine and upright positioning for children with moderate to complex needs. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05059804143005 EUDAMEDFDA UDI
- Basic UDI-DI
- 05059804102StandingEW EUDAMED
- Direct Marketing DI
- 05059804143005 EUDAMED
- FDA Product Code
- INM FDA UDI
- EMDN Code
- Y050202 STANDING FRAMES EUDAMED
- GMDN Term
- Manual stander/exerciser 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
Mygo Stander 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- James Leckey Design Ltd
- EUDAMED SRN
- XI-MF-000003572
Sources (2)
- EUDAMED d359732d-312c-42cb-a553-666c6e52eeb7 61 fields · synced Jul 13, 2026
- FDA UDI 0ccafd10-2b81-45b8-a28e-596e2e7b1353 33 fields · synced May 30, 2026