AccessGUDID - DEVICE: G5® (00746980001346)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: 00746980001346
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 098639974 *Terms of Use

Device Description: The G5 GK-3 is a quiet & powerful Massage Machine designed for rugged use in the office, clinic, school, gym, training room or home. Each GK-3 has a 47 3/4" long, light-weight, smooth drive cable attached to a durable applicator head, to provide greater versatility and ease of use. The GK-3 incorporates a dial-controlled, variable-speed output, with speeds from 20 - 60 cycles per second. Unit Advantages: Economical Stand Mount or Portable Configurations Basic Control Panel with CPS Indicator (Low, Medium, High) Comes complete with choice of applicator package

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: 34 Pound

Device Record Status

Public Device Record Key: 81cbbd88-55dc-4ad5-a1f7-0340f595bee4
Public Version Date: June 06, 2024
Public Version Number: 6
DI Record Publish Date: April 26, 2017