AccessGUDID - DEVICE: E-Pacer (00858101008292)

GUDID

Device Identifier (DI) Information

Brand Name: E-Pacer
Version or Model: K660
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: RIFTON EQUIPMENT

Primary DI Number: 00858101008292
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 808251438 *Terms of Use

Device Description: Powered gait trainer and transfer device

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
63674	Gait rehabilitation electronic walker	An 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FSA	Lift, Patient, Non-Ac-Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b48d70a5-d821-4ee6-9be6-7f6ecc0e9559
Public Version Date: September 21, 2022
Public Version Number: 1
DI Record Publish Date: September 13, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 800.571.8198
Email: sales@rifton.com

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