Identity
- Trade Name
- Totstander EUDAMEDLeckey Totstander FDA UDI
- Generic Name
- Manual stander/exerciser FDA UDI
- Device Name
- Standing EUDAMEDThe Totstander promotes active standing, movement and weight shifting and can be used as a stander or by therapists as an evaluation tool to assess a child’s standing ability. FDA UDI
- Model / Reference
- LFS/T EUDAMEDTotstander FDA UDI
- Description
- The Totstander promotes active standing, movement and weight shifting and can be used as a stander or by therapists as an evaluation tool to assess a child’s standing ability. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05059804100008 EUDAMEDFDA UDI
- Basic UDI-DI
- 05059804102StandingEW EUDAMED
- Direct Marketing DI
- 05059804100008 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
Totstander 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 51f261e5-560b-4949-901b-e23870db7417 61 fields · synced Jun 19, 2026
- FDA UDI d6b3787f-528e-46f7-9a65-76db6f940af7 33 fields · synced May 30, 2026