AccessGUDID - DEVICE: G5® (00746980001032)

GUDID

Device Identifier (DI) Information

Brand Name: G5®
Version or Model: PP 24 B
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PP 24 B
Company Name: GENERAL PHYSIOTHERAPY INC

Primary DI Number: 00746980001032
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 098639974 *Terms of Use

Device Description: The G5 Pro-Power 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 Pro-Power Massager 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. Excellent for the relief of, repair of, and resistance to repetitive motion disorders. (Carpal Tunnel Syndrome, tendonitis, tenosynovitis, etc.) The head of the G5 Pro-Power accepts all genuine G5 Brand massage applicators. Unit Advantages: Portable: only 12" long Lightweight: weighs only 3 lbs. Hand-held device with a soft rubber grip Variable speed control: 20 - 50 cycles per second

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?
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.	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: 3 Pound

Device Record Status

Public Device Record Key: c51f4950-6f22-41d9-9b91-e75283eb1c57
Public Version Date: September 29, 2020
Public Version Number: 4
DI Record Publish Date: April 25, 2017