Vive

Basic Information

• Brand Name: Vive
• Primary DI: 00810178880201
• Version / Model: SUP3096BLKXL
• Company Name: VIVE HEALTH LLC
• Labeler DUNS: 047025993
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-07-08
• Public Version: 1
• Public Version Date: 2025-07-16
• Public Version Status: New
• Public Device Record Key: f01d23f1-9293-433b-a529-4dcc947d5bd2

Device Description

Shoe Lift Balancer (XL)

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: Yes
• 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
KNP	Orthosis, Corrective Shoe	Physical Medicine	890.3475	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42791	Shoe/boot antislip device	A device designed to be applied to the outer sole of the shoes or boots of an elderly person or a person with a disability to provide them with greater grip between their footwear and the surface upon which they are walking. It is typically attached to the footwear with clips, bands, or springs, and is used to help prevent slipping and falls typically in winter conditions.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10810178880208	GS1	Case	32	In Commercial Distribution
Primary	00810178880201	GS1