AccessGUDID - DEVICE: Golden State Medical HD Combo (00860001588309)

GUDID

Device Identifier (DI) Information

Brand Name: Golden State Medical HD Combo
Version or Model: ECS322P
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: International Trade Group Inc

Primary DI Number: 00860001588309
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079427100 *Terms of Use

Device Description: GSM HD Combo Transcutaneous Electrical Nerve Stimulation (TENS): The device is intended for the temporary relief of pain associated with sore and aching muscles in the lower back, upper extremities (arms) and lower extremities (legs) due to strain from exercise and/or normal household and work activities. GSM HD Combo Neuromuscular electrical stimulation (NMES): The device is intended to stimulate muscles in order to facilitate and improve muscle performance.

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":	Yes
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	Yes
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?
46573	Physical therapy transcutaneous neuromuscular electrical stimulation system	An electrically-powered device assembly intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes; it is not intended for tremor suppression. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter

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
Storage Environment Temperature: between -25 and 70 Degrees Celsius
Handling Environment Temperature: between 5 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Height: 128 Millimeter
Width: 67 Millimeter
Depth: 25 Millimeter
Weight: 0.12 Kilogram

Device Record Status

Public Device Record Key: e4517bb2-a6ec-4ac4-bb2d-e0e27adedd4b
Public Version Date: October 20, 2023
Public Version Number: 1
DI Record Publish Date: October 12, 2023