G5®

Basic Information

• Brand Name: G5®
• Primary DI: 00746980001650
• Version / Model: ALC 240 G5
• Catalog Number: ALC 240 G5
• Company Name: GENERAL PHYSIOTHERAPY INC
• Labeler DUNS: 098639974
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-05-01
• Public Version: 4
• Public Version Date: 2020-09-28
• Public Version Status: Update
• Public Device Record Key: 22a2de93-f1b9-4eec-8984-a69357f83452

Device Description

The G5® ALC Over-The-Shoulder Massage Machine produces a non-invasive therapy treatment for skin, scalp, tissue, muscles, lymph nodes and the circulatory system. A wide array of applicators combine with the ALC unit to provide aesthetic services such as cellulite reduction, exfoliation, lymphatic drainage, body contouring, skin toning and muscle relaxation. Comes complete with caster stand, accessory tray, and applicators. Unit Advantages: • Versatility: Pole, Table Top • Portability: In-mold handle and smooth casters to easily move from room to room • CPS Indicator on Control Panel • Extra tall stand so cable can hang over the operator’s shoulder for ease of use

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
35538	Large-area electric massager	An electrically-powered device designed to provide therapeutic massage to a larger area than hand-held massaging devices. It may utilize vibrating belts or other interchangeable mechanisms that are applied to the body to mechanically stimulate the musculature or provide other physiotherapy treatment. This device is intended for use in healthcare facilities and is not applicable to home therapies.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00746980001650	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Weight	38	Pound