Leckey Ealy Activity System

Basic Information

• Brand Name: Leckey Ealy Activity System
• Primary DI: 05059804130005
• Version / Model: Early Activity System
• Company Name: SUNRISE MEDICAL (US) LLC
• Labeler DUNS: 962525056
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-07
• Public Version: 1
• Public Version Date: 2023-10-16
• Public Version Status: New
• Public Device Record Key: db838f7c-8252-4a22-a399-136d91254b0a

Device Description

The Leckey Early Activity System is a Colorful, comfortable, supportive activity system for children aged 0-36 months.

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: Yes
• 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: Yes
• 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
ILS	Adaptor, Hygiene	Physical Medicine	890.5050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44417	Gymnasium mat	A deviced that is placed upon the floor upon which a person can move on a soft surface intended for training and rehabilitation to regain and/or improve body movement and balance and/or for strengthening the limbs and the trunk of the body. It will typically be used by a person with a disability. It consists of a padded mat that is typically square or oblong in shape upon which the person moves around in safe, floor-level positions and/or can perform gymnastic movements.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05059804130005	GS1