Model: MOB1146BLU14
DI: 00810178884865
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: Yes
First Published: 2026-04-26
Current Version: 2026-05-04
Description
Reclining Pediatric Wheelchair (14")
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
500010db-0c3f-484b-9d5a-8aeee2c32e55
Distribution Status:
In Commercial Distribution
DUNS Number:
047025993
Device Count:
1
DM Exempt:
Yes
Premarket Exempt:
No
HCT/P:
Yes
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00810178884865
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 41630
Name: Attendant-only-propelled wheelchair, non-bariatric
Definition:
A non-powered wheeled mobility device with a seat designed to enable a healthcare provider/carer to transport a non-bariatric person without the full capacity to walk, typically over short distances and over smooth ground. Often referred to as a transport wheelchair, it is typically designed with four small wheels and includes rear-fitted handles for attendant control of the chair; it does not provide the occupant a mechanism for self-propulsion (it is not a push-rim wheelchair). It provides no function outside of wheeled mobilization.
FDA Product Codes
IOR
Wheelchair, Mechanical
Premarket Submissions
Submission Number:
K053574
Supplement Number:
000