Relaxis

Basic Information

• Brand Name: Relaxis
• Primary DI: 00852335007052
• Version / Model: 09-0021-02
• Company Name: Relaxis
• Labeler DUNS: 963372995
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 4
• Public Version Date: 2020-07-16
• Public Version Status: Update
• Public Device Record Key: 70c24372-895b-4959-af2a-c91a3321717f
• Distribution End Date: 2019-08-31

Device Description

Packaged, Relaxis Battery, Medium

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• Has Lot/Batch Number: Yes
• 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
OVP	Vibratory Counter-Stimulation	Physical Medicine	882.5895	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62210	Restless legs syndrome vibratory counterstimulation system	A mains electricity (AC-powered) device assembly, which may include rechargeable batteries, intended to reduce the symptoms of Restless Legs Syndrome (RLS) and improve sleep through vibratory counterstimulation. It includes a controller and a vibratory pad which is placed in contact with the patient’s legs whilst in bed to reduce the sensation of restless legs. It is intended for use in the home.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00852335007052	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Medium