TWISTER

Basic Information

• Brand Name: TWISTER
• Primary DI: 00606509900140
• Version / Model: TWISTER
• Catalog Number: N/A
• Company Name: Pride Mobility Products Corp
• Labeler DUNS: 041477449
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-08-26
• Public Version: 2
• Public Version Date: 2023-03-03
• Public Version Status: Update
• Public Device Record Key: 26e43472-b980-462e-a9ab-c5aa4da5b35a

Device Description

A device designed to assist a person with a disability in the techniques of selecting the correct input device in order to operate a connected primary device.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: No
• PM Exempt: Yes
• Has Serial Number: Yes
• 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
KNO	Accessories, Wheelchair	Physical Medicine	890.3910	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42854	Assistive input-control operation training device, selection techniques	A device designed to assist a person with a disability in the techniques of selecting the correct input device, e.g., a switch or a keyboard, in order to operate a connected primary device (e.g., a wheelchair or a computer).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00606509900140	GS1