VIVE

Basic Information

• Brand Name: VIVE
• Primary DI: 00818323028324
• Version / Model: RHB2000
• Company Name: VIVE HEALTH LLC
• Labeler DUNS: 047025993
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-17
• Public Version: 1
• Public Version Date: 2019-07-25
• Public Version Status: New
• Public Device Record Key: b8c39a01-732d-4a18-ae04-ce943f77c7e4

Device Description

Foot Stretcher

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
OHI	Orthosis, Foot Drop	Physical Medicine	890.3475	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63490	Paediatric dorsiflexion slant board	A standing platform for a child designed to slant the surface on which the feet are placed to create a slope angle to therapeutically stretch the ankle plantar flexion muscles/tendons. It is intended to be used in the treatment of various medical conditions (e.g., congenital, neurological, post-traumatic) where tendon tightness and muscle contracture affect the ability to dorsiflex the foot, possibly leading to an abnormal gait. It is typically made of synthetic polymer materials. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10818323028321	GS1	Case	42	In Commercial Distribution
Primary	00818323028324	GS1