AccessGUDID - DEVICE: Leckey Horizon 2 (05059804101029)

GUDID

Device Identifier (DI) Information

Brand Name: Leckey Horizon 2
Version or Model: Horizon Size 2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SUNRISE MEDICAL (US) LLC

Primary DI Number: 05059804101029
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 962525056 *Terms of Use

Device Description: The individually adjustable chest, hip and knee pads along with the footplates, provide unsurpassed levels of adjustability for proximal positioning - making the Horizon ideal for more complex users or adults who have not benefitted from standing therapy for some time. The Horizon range enables the safe and easy transfer of users using either mobile or tracking hoists.

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":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
61700	Manual stander	A manually-powered, mobile device designed to support and lift a disabled (paraplegic) patient to an upright standing position to provide the health benefits associated with standing (e.g., improved breathing, circulation, and flexibility); it is neither intended to facilitate gait nor assist standing transfer. It typically consists of a seat, sling and/or platform with appropriate supports (e.g., footplates, kneepads, chest pad), wheels, and a manual mechanical lifting mechanism whereby the patient is raised from a supine, prone, and/or seated position by themselves or with the assistance of a healthcare provider. It includes wheels for reorientation.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
INM	Chair, With Casters

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: 72943cd5-2689-4f6b-a0c8-f99d8a5f9f78
Public Version Date: May 20, 2025
Public Version Number: 2
DI Record Publish Date: September 24, 2023