Device
4 Wheel Air Frame Walker with Bag (Grey w/ Black Bag)
Manufacturer
VIVE HEALTH LLC
Model: MOB1148GRYBLK DI: 00810178885022 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: No OTC: Yes
First Published: 2026-04-27 Current Version: 2026-05-05
Description
4 Wheel Air Frame Walker with Bag (Grey w/ Black Bag)
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 27c078cc-ea6e-4dcd-ab37-97c6e90b6d3e
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: 00810178885022
Type: Primary
Issuing Agency: GS1
GMDN
Code: 37951
Name: Handgrip disability-assistive walker, non-powered, foldable
Definition:
A non-powered, all- or partially-wheeled mobility aid in the form of a waist-high, foldable framework with handgrips and three or four legs designed to provide a stable support for a patient with a walking disability, a geriatric, obese, or infirm patient when standing or ambulating; it may also be used during rehabilitation. It is constructed of lightweight metal, plastic, and rubber materials and in the form of a mobile support structure which the patient holds and pushes in front of them as they walk. It is foldable for storage and transportation and may include a braking mechanism; it may be width-adjustable and some types may include a seat on which the patient can rest.
FDA Product Codes
ITJ
Walker, Mechanical