Handicare

Basic Information

• Brand Name: Handicare
• Primary DI: 00810045517285
• Version / Model: 510431
• Company Name: HANDICARE USA, INC.
• Labeler DUNS: 800145836
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-08
• Public Version: 1
• Public Version Date: 2022-09-16
• Public Version Status: New
• Public Device Record Key: c2683d74-1501-4b54-9914-7ea6bda3dbfa

Device Description

Rehab Walking Sling - Leg Straps Assembly (X-Large)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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
FSA	Lift, Patient, Non-Ac-Powered	General Hospital	880.5510	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35961	Patient lifting system lift pants	A lifting device used together with a mobile lift system (normally a ceiling-mounted overhead track system) to provide a support for an incapacitated patient or a person with a disability that has been raised from a sitting position and held in a standing position for mobility training; it is primarily used for confidence building when walking. It is designed as a sling construction made of straps attached to a pants-like holder which is placed between the users' legs (the crotch) and secured high around the waist which will cradle the hip section of their body allowing them to maintain balance whilst moving slowly forward using their feet. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810045517285	GS1