AccessGUDID - DEVICE: G5® (00746980001650)

GUDID

Device Identifier (DI) Information

Brand Name: G5®
Version or Model: ALC 240 G5
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ALC 240 G5
Company Name: GENERAL PHYSIOTHERAPY INC

Primary DI Number: 00746980001650
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 098639974 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35538	Freestanding electric massager	An electrically-powered benchtop, mobile, or stationary device designed to provide therapeutic massage to a larger area than hand-held massaging devices. It may be in the form of a vibrating bed or a tabletop/freestanding unit with a massaging handpiece or other interchangeable mechanisms that are applied to the body to mechanically stimulate the musculature or provide other physiotherapy treatment; it may additionally provide heat. This device is intended for use in healthcare facilities and is not applicable to home therapies.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ISA	Massager, Therapeutic, Electric

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Weight: 38 Pound

Device Record Status

Public Device Record Key: 22a2de93-f1b9-4eec-8984-a69357f83452
Public Version Date: June 06, 2024
Public Version Number: 5
DI Record Publish Date: May 01, 2017