JWX-2

Basic Information

• Brand Name: JWX-2
• Primary DI: 05022408056767
• Version / Model: XT
• Catalog Number: XT
• Company Name: SUNRISE MEDICAL (US) LLC
• Labeler DUNS: 962525056
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-23
• Public Version: 4
• Public Version Date: 2021-11-30
• Public Version Status: Update
• Public Device Record Key: 086aad39-d6ba-47ce-89dc-4f64b35b3ed6
• Distribution End Date: 2021-05-03

Device Description

Electric Power assist Unit for Wheelchairs

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• 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
ITI	Wheelchair, powered	Physical Medicine	890.3860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38529	Wheelchair, power-assisted, occupant-controlled, non-collapsible	A wheeled personal mobility device that incorporates a seat-support system for a person with a disability or a person without the full capacity to walk (not bariatric) designed to be manually propelled and steered by the rotation of both rear wheels by the occupant, and when needed, power from an electric motor replaces manual wheel rotation. The device cannot be folded or readily dismantled for transport. Typically, the user is a paraplegic or quadriparetic person who desires to manually propel himself as much as possible for the exercise. The power assist feature is enabled to climb inclines, for extended distance travel, or when the user fatigues.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05022408056767	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K140204	000