Device
Heavy Duty Wheelchair (22")
Manufacturer
VIVE HEALTH LLC
Model: MOB1150BLK22 DI: 00810178885961 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: No OTC: Yes
First Published: 2026-04-26 Current Version: 2026-05-04
Description
Heavy Duty Wheelchair (22")
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 415af057-4656-41cd-84fd-b1c56c77d0ec
Distribution Status: In Commercial Distribution
DUNS Number: 047025993
Device Count: 1
DM Exempt: Yes
Premarket Exempt: Yes
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: No
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: 00810178885961
Type: Primary
Issuing Agency: GS1
GMDN
Code: 66679
Name: Push-rim manual wheelchair, bariatric
Definition:
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.
FDA Product Codes
IOR
Wheelchair, Mechanical