Golden State Medical HD Combo

GUDID 00860001588309

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.

International Trade Group Inc

Physical therapy transcutaneous neuromuscular electrical stimulation system
Primary Device ID00860001588309
NIH Device Record Keye4517bb2-a6ec-4ac4-bb2d-e0e27adedd4b
Commercial Distribution StatusIn Commercial Distribution
Brand NameGolden State Medical HD Combo
Version Model NumberECS322P
Company DUNS079427100
Company NameInternational Trade Group Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Countertrue

Customer Support Contacts

Phone6146572881
Emailbcr88@frontier.com
Phone6146572881
Emailbcr88@frontier.com
Phone6146572881
Emailbcr88@frontier.com
Phone6146572881
Emailbcr88@frontier.com
Phone6146572881
Emailbcr88@frontier.com
Phone6146572881
Emailbcr88@frontier.com
Phone6146572881
Emailbcr88@frontier.com
Phone6146572881
Emailbcr88@frontier.com
Phone6146572881
Emailbcr88@frontier.com
Phone6146572881
Emailbcr88@frontier.com
Phone6146572881
Emailbcr88@frontier.com
Phone6146572881
Emailbcr88@frontier.com
Phone6146572881
Emailbcr88@frontier.com
Phone6146572881
Emailbcr88@frontier.com
Phone6146572881
Emailbcr88@frontier.com
Phone6146572881
Emailbcr88@frontier.com
Phone6146572881
Emailbcr88@frontier.com
Phone6146572881
Emailbcr88@frontier.com

Device Dimensions

Height128 Millimeter
Width67 Millimeter
Depth25 Millimeter
Weight0.12 Kilogram
Height128 Millimeter
Width67 Millimeter
Depth25 Millimeter
Weight0.12 Kilogram
Height128 Millimeter
Width67 Millimeter
Depth25 Millimeter
Weight0.12 Kilogram
Height128 Millimeter
Width67 Millimeter
Depth25 Millimeter
Weight0.12 Kilogram
Height128 Millimeter
Width67 Millimeter
Depth25 Millimeter
Weight0.12 Kilogram
Height128 Millimeter
Width67 Millimeter
Depth25 Millimeter
Weight0.12 Kilogram
Height128 Millimeter
Width67 Millimeter
Depth25 Millimeter
Weight0.12 Kilogram
Height128 Millimeter
Width67 Millimeter
Depth25 Millimeter
Weight0.12 Kilogram
Height128 Millimeter
Width67 Millimeter
Depth25 Millimeter
Weight0.12 Kilogram
Height128 Millimeter
Width67 Millimeter
Depth25 Millimeter
Weight0.12 Kilogram
Height128 Millimeter
Width67 Millimeter
Depth25 Millimeter
Weight0.12 Kilogram
Height128 Millimeter
Width67 Millimeter
Depth25 Millimeter
Weight0.12 Kilogram
Height128 Millimeter
Width67 Millimeter
Depth25 Millimeter
Weight0.12 Kilogram
Height128 Millimeter
Width67 Millimeter
Depth25 Millimeter
Weight0.12 Kilogram
Height128 Millimeter
Width67 Millimeter
Depth25 Millimeter
Weight0.12 Kilogram
Height128 Millimeter
Width67 Millimeter
Depth25 Millimeter
Weight0.12 Kilogram
Height128 Millimeter
Width67 Millimeter
Depth25 Millimeter
Weight0.12 Kilogram
Height128 Millimeter
Width67 Millimeter
Depth25 Millimeter
Weight0.12 Kilogram

Operating and Storage Conditions

Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100860001588309 [Primary]

FDA Product Code

NGXStimulator, Muscle, Powered, For Muscle Conditioning

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-20
Device Publish Date2023-10-12

Devices Manufactured by International Trade Group Inc

00860001588309 - Golden State Medical HD Combo2023-10-20GSM 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.
00860001588309 - Golden State Medical HD Combo2023-10-20 GSM HD Combo Transcutaneous Electrical Nerve Stimulation (TENS): The device is intended for the temporary relief of pain associa
00860001588316 - Pain Warrior2023-10-20 TENS: The device is intended to be used for the temporary relief of pain associated with sore and aching muscles in the lower ba
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