G5®

Basic Information

• Brand Name: G5®
• Primary DI: 00746980002190
• Version / Model: ME 600
• Catalog Number: ME 600
• Company Name: GENERAL PHYSIOTHERAPY INC
• Labeler DUNS: 098639974
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-06-12
• Public Version: 4
• Public Version Date: 2020-10-08
• Public Version Status: Update
• Public Device Record Key: 9f4b31b4-104c-47a0-9097-48da6385472d

Device Description

The G5 ME 600 Professional Portable Massager is our most powerful hand-held device. It incorporates the powerful massage action of our stand-mounted G5 Massage Machines into a small, compact, hand-held unit - a massager small enough on the outside to fit in a gym bag, but big enough on the inside to consistently deliver a powerful, deep-penetrating massage action. The G5 ME 600 is ideal for the athletic trainers or athletes on the go! Comes with our Professional Portable Applicator Package. G5 Travel Bag sold seperately. The G5 ME 600 massager is beneficial to anyone who competes, works out, or is involved in strenuous work. Before an activity, use it to enhance flexibility, increase range-of-motion, and reduce the risk of muscle spasms, strains or contusions. After exertion, rely on the G5 ME 600 to accelerate the healing process, to reduce pain and swelling by flushing out lactic acid buildup in the muscles, and to relieve muscle pain caused by work and stress. Unit Advantages: Portable device with the same quality and durability as our larger models Ergonomical grip points for convenient one or two handed operation. Variable speed control: 15 - 55 cycles per second

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• Has Manufacturing Date: Yes
• 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
ISA	Massager, Therapeutic, Electric	Physical Medicine	890.5660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36560	Hand-held electric massager	An electrically-powered device with a vibrating head, or pads, designed to be held in the hand and drawn across the area of the body/muscles to be treated. The vibrating head, or pads, may optionally be heated, and may be interchangeable with others of different size and shape. It is typically used for respiratory therapy or physiotherapy (e.g., help reduce muscular tension, arthritic pain or joint mobility) in the home and/or healthcare facility.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00746980002190	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Weight	8	Pound