Model: Pathan
DI: 06975028630581
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-21
Current Version: 2026-05-29
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
1dde879f-e5a2-4786-ba90-a378683d909b
Distribution Status:
In Commercial Distribution
DUNS Number:
709462082
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
06975028630581
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 41875
Name: Electric-motor-driven wheelchair, occupant-controlled
Definition:
An electrically-powered wheeled personal mobility device with a seat designed to enable a non-bariatric person with a disability, or without the full capacity to walk, to self-mobilize using power from an electric motor(s). It includes controls (typically joystick) to allow the occupant electronic control of speed/direction; it is not designed with a foot platform and handlebars (i.e., not a mobility scooter).
FDA Product Codes
ITI
Wheelchair, Powered
Premarket Submissions
Submission Number:
K240638
Supplement Number:
000