DEVICE: Merlexi Craft (00860000595414)
Device Identifier (DI) Information
Merlexi Craft
Merlexi Craft Bariatric
In Commercial Distribution
Turbo Wheelchair Company, Inc.
Merlexi Craft Bariatric
In Commercial Distribution
Turbo Wheelchair Company, Inc.
Plastic manual wheelchair, for bariatric users up to 425 pounds.
Device Characteristics
MR Unsafe | |
No | |
No | |
No | |
No | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
66679 | Push-rim manual wheelchair, bariatric |
A non-powered wheeled personal mobility device with an oversized seat designed to enable a bariatric person without the full capacity to walk to self-mobilize by pushing specially designed rims on the wheels while seated. It is designed with a pair of larger wheels with push-rims attached whereby the occupant propels the device by rotating both wheels; it typically includes rear-fitted handles designed for optional pushing by an attendant. It provides no function outside of wheeled mobilization.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
IOR | Wheelchair, Mechanical |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K240120 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
3c822028-bb46-4367-be93-bc56c5fe81cd
July 19, 2024
1
July 11, 2024
July 19, 2024
1
July 11, 2024
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
5026148032
merlinchair@gmail.com
merlinchair@gmail.com