Valmax

Basic Information

• Brand Name: Valmax
• Primary DI: 06974231101284
• Version / Model: DME.015
• Company Name: Supply Line Medical
• Labeler DUNS: 117011784
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-21
• Public Version: 2
• Public Version Date: 2025-02-20
• Public Version Status: Update
• Public Device Record Key: 2d20dbab-c863-4227-bca7-e2eb1420dde5
• Distribution End Date: 2025-01-21

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: No
• 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
IOR	Wheelchair, Mechanical	Physical Medicine	890.3850	1

GMDN Terms

Code	Name	Definition	Implantable	Status
67034	Manual traction wheelchair	A dedicated, non-powered, wheeled mobility device with a seat designed to enable occupant mobilization while facilitating spinal traction in conjunction with a skull-attached halo ring (not included) for a patient with a spinal disorder (e.g., kyphosis, scoliosis). It is designed as a push-rim wheelchair with rear-fitted handles, and a suspension frame with an overhead pulley(s) and a cable. Traction is achieved by forces from weights or springs applied to the cable connected to the halo ring. It is only intended for use in a healthcare facility, typically to stretch the spine prior to surgical correction.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06974231101284	GS1

Premarket Submissions

Submission Number	Supplement Number
K112816	000