Identity
- Trade Name
- Merlexi Craft FDA UDI
- Generic Name
- Push-rim manual wheelchair, bariatric FDA UDI
- Device Name
- Plastic manual wheelchair, for bariatric users up to 425 pounds. FDA UDI
- Model / Reference
- Merlexi Craft Bariatric FDA UDI
- Description
- Plastic manual wheelchair, for bariatric users up to 425 pounds. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860000595414 FDA UDI
- 510(k) Number
- K240120 FDA UDI
- FDA Product Code
- IOR FDA UDI
- GMDN Term
- Push-rim manual wheelchair, bariatric FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3850 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Push-rim manual wheelchair, bariatric
Merlexi Craft by Turbo Wheelchair Co., Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Turbo Wheelchair Co., Inc.
Sources (1)
- FDA UDI 3c822028-bb46-4367-be93-bc56c5fe81cd 35 fields · synced Jun 8, 2026