FDA.reportPublic FDA data

Large Pacer

Primary DI
00858101008278
Brand
Large Pacer
Company
RIFTON EQUIPMENT
Model
K640
Device description
Gait Trainer
Published
2022-09-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
ITJWalker, Mechanical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITJWalker, MechanicalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858101008278PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858101008278008581010082788581010082780858101008278

GMDN Terms#

Term, Definition table
TermDefinition
Gait rehabilitation frame, manualA manually-operated, body-weight unloading, gait rehabilitation device designed to assist a patient with a walking/balance disability (neurogenic, muscular, or osseous in origin) regain lost motor function, by enabling them to hang in a dedicated harness in a vertical position and exercise (e.g., walk over the ground or moving surface of an elliptical/treadmill, climb stairs, perform sit-to-stand movements). It consists of a ceiling- or wall-mounted beam, or floor-standing frame with a manual attachment assembly connected to the harness which supports the body weight. It is intended to be used in a clinical setting under professional supervision.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800.571.8198sales@rifton.com

Regulatory Flags#

DUNS number
808251438
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850001752473"32"" x 24"" Adaptive Desk"R2402025-07-15
00858101008049Large Supine StanderE4302022-09-16
00858101008100Medium Prone StanderE9402022-09-16
00858101008117Large Prone StanderE9502022-09-16
00858101008186TRAMK3102022-09-16
00858101008193TRAM Low BaseK3202022-09-16
00850001752244Small PacerK6202022-09-13
00858101008261Medium PacerK6302022-09-13
00858101008285XL PacerK6502022-09-13
00850001752237Mini PacerK6102022-09-09
00850001752367Size 3 StanderS4302025-02-07
00850001752428Adaptive DeskR2502025-02-04
00858101008704Small Hygiene and Toileting SystemZ1102022-09-16
00858101008742Medium Hygiene and Toileting SystemZ1202022-09-16
00858101008773Large Hygiene and Toileting SystemZ1302022-09-16
00850001752350Size 2 StanderS4202024-06-24
00858101008032Small Supine StanderE4202022-09-16
00858101008094Small Prone StanderE9302022-09-16
00850001752336Size 1 StanderS4102023-07-22
00850001752329Small TricycleX3202023-06-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06977176610248BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610255BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610262BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610279BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610286BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610293BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610309BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610316BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610323BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610330BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610347BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610354BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610361BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610378BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610385BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610392BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610408BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610415BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610422BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610439BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610446BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610453BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610460BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610477BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610484BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610491BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610507BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610514BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610521BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610538BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25