FDA.reportPublic FDA data

LiteGait

Primary DI
00850040235012
Brand
LiteGait
Company
Mobility Research, Inc.
Model
ALL LiteGait devices
Catalog number
N/A
Device description
LiteGait is a Physical Therapy Patient lifting device that allows for body weight support gait therapy.
Published
2023-07-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FSALift, Patient, Non-Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSALift, Patient, Non-Ac-PoweredGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850040235012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850040235012008500402350128500402350120850040235012

GMDN Terms#

Term, Definition table
TermDefinition
Gait rehabilitation system harnessA lifting device, in the form of belts and straps, which is a component of a gait rehabilitation system designed to assist a patient with a walking disability (neurogenic, muscular, or osseous in origin) regain lost motor function. The device is designed to be secured around the patient?s upper body and hips and is intended to help suspend the patient vertically over the floor or a treadmill while attached to the supporting frame of a suspension device; it may be used in conjunction with a robotic orthosis device for the training of normal gait.

Regulatory Flags#

DUNS number
941395493
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850040235005GaitKeeperAll GaitKeeper devices2023-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344204540MEDLINEMEDLINE INDUSTRIES, INC.FSA2026-09-04
10197344204557MEDLINEMEDLINE INDUSTRIES, INC.FSA2026-09-04
10197344204564MEDLINEMEDLINE INDUSTRIES, INC.FSA2026-09-04
10688503002140M-SERIESSavaria Concord LiftFSA2026-08-26
00810055885428SLING,QFIT PAD,SOLID,SMALLJOERNS HEALTHCARE, LLCFSA2026-08-25
00810055885435SLING,QFIT PAD,SOLID,MEDIUMJOERNS HEALTHCARE, LLCFSA2026-08-25
00810055885442SLING,QFIT,NET,MEDIUMJOERNS HEALTHCARE, LLCFSA2026-08-25
00810055885459SLING,QFIT PAD,SOLID,LARGEJOERNS HEALTHCARE, LLCFSA2026-08-25
00810055885466SLING,QFIT DLUX,SOLID,SMALLJOERNS HEALTHCARE, LLCFSA2026-08-25
00810055885473SLING,QFIT DLUX,SOLID,MEDIUMJOERNS HEALTHCARE, LLCFSA2026-08-25
00810055885480SLING,QFIT DLUX,NET,MEDIUMJOERNS HEALTHCARE, LLCFSA2026-08-25
00810055885497SLING,QFIT DLUX,SOLID,LARGEJOERNS HEALTHCARE, LLCFSA2026-08-25
00810055885503SLING,QFIT DLUX,NET,LARGEJOERNS HEALTHCARE, LLCFSA2026-08-25
00810055885510SLING,L/S PLAIN,SOLID,SMALLJOERNS HEALTHCARE, LLCFSA2026-08-25
00810055885527SLING,L/S PLAIN,NET,MEDIUMJOERNS HEALTHCARE, LLCFSA2026-08-25
00810055885534SLING,STANDING DLUX,SOLID,LARGEJOERNS HEALTHCARE, LLCFSA2026-08-25
00810055885541SLING,STANDING DLUX,SOLID,SMALLJOERNS HEALTHCARE, LLCFSA2026-08-25
00810055885558SLING,STANDING DLUX,SOLID,MEDIUMJOERNS HEALTHCARE, LLCFSA2026-08-25
00810055885565SLING,TRANSPORT DLUX,SOLID,MEDIUMJOERNS HEALTHCARE, LLCFSA2026-08-25
00810055885572SLING,TRANSPORT DLUX,SOLID,SMALLJOERNS HEALTHCARE, LLCFSA2026-08-25
00810055885589SLING,TRANSPORT DLUX,SOLID,LARGEJOERNS HEALTHCARE, LLCFSA2026-08-25
00810055885596SLING,COMFORT PAD,SOLID,SMALL,4PTJOERNS HEALTHCARE, LLCFSA2026-08-25
00810055885602SLING,COMFORT PAD,SOLID,MEDIUM,4PTJOERNS HEALTHCARE, LLCFSA2026-08-25
00810055885619SLING,COMFORT PAD,SOLID,LARGE,4PTJOERNS HEALTHCARE, LLCFSA2026-08-25
00810055885626SLING,COMFORT PAD,SOLID,XL,4PTJOERNS HEALTHCARE, LLCFSA2026-08-25
00810055885633SLING,COMFORT,NET,MEDIUM,4PTJOERNS HEALTHCARE, LLCFSA2026-08-25
00810055885640SLING,COMFORT,NET,LARGE,4PTJOERNS HEALTHCARE, LLCFSA2026-08-25
00810055885657SLING,COMFORT,NET,XL,4PTJOERNS HEALTHCARE, LLCFSA2026-08-25
00810055885664SLIDE SHEET,NYLON,SMALLJOERNS HEALTHCARE, LLCFSA2026-08-25
00810055885671SLIDE SHEET,NYLON,MEDIUMJOERNS HEALTHCARE, LLCFSA2026-08-25