FDA.reportPublic FDA data

E-Pacer

Primary DI
00858101008292
Brand
E-Pacer
Company
RIFTON EQUIPMENT
Model
K660
Device description
Powered gait trainer and transfer device
Published
2022-09-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
00858101008292PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858101008292008581010082928581010082920858101008292

GMDN Terms#

Term, Definition table
TermDefinition
Gait rehabilitation electronic walkerAn all-wheeled, battery-powered device designed to assist a patient with a walking disability (neurogenic, muscular, or orthopaedic in origin) to regain lost motor function, which may include rising from sitting to standing and/or ambulation over ground (not on a treadmill). It consists of a mobile rigid framework, on non-powered wheels, which includes a platform intended for forearm/elbow support and a patient harness; handgrips; and an electronic control unit for powered functions such as variable height support. It is intended to be used in a clinical setting (e.g., gait lab, rehabilitation centre, nursing home) under healthcare 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
00858101008278Large PacerK6402022-09-13
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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05404016614032Handi-Move SlingHandi-MoveFSA2026-06-02
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