Kaye Products - DS4

Basic Information

• Brand Name: Kaye Products - DS4
• Primary DI: 00810117142766
• Version / Model: DS4
• Company Name: Kaye Products, Inc.
• Labeler DUNS: 082364654
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-05
• Public Version: 1
• Public Version Date: 2023-07-13
• Public Version Status: New
• Public Device Record Key: a3746a0d-a3aa-435d-a21d-d9f1d1a3641b

Device Description

Large Dynamic Stander

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ILT	Adaptor, Recreational	Physical Medicine	890.5050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61704	Manual stander/exerciser	A manually-powered device designed to support and lift a disabled (paraplegic) patient to an upright standing position, and to enable the occupant to perform an exercise, to provide the health benefits associated with standing/exercising; it is neither intended to facilitate gait, provide patient mobility, nor assist standing transfer. It typically consists of a seat and/or platform with appropriate supports (e.g., footplates, kneepads, chest pad), an exercise mechanism (e.g., moveable handles with reciprocal leg movement), and a manual mechanical lifting mechanism; the patient is raised from a supine and/or seated position by themselves or with the assistance of a healthcare provider.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810117142766	GS1