Pain Warrior 77621

GUDID 00860001588316

TENS: The device is intended to be used 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 and/or normal non-commercial household work activities. Programs 01 to 07, and HAN are TENS programs. NMES: The device is intended to be used to stimulate healthy muscles in order to facilitate and improve muscle performance. Programs 08 to 13 are NMES programs. The device should be used for these purposes

International Trade Group Inc

Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system
Primary Device ID00860001588316
NIH Device Record Key6d336564-07e9-4067-b544-76f94493d65b
Commercial Distribution StatusIn Commercial Distribution
Brand NamePain Warrior
Version Model NumberECS322
Catalog Number77621
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

Weight0.09 Kilogram
Height106 Millimeter
Width62 Millimeter
Depth62 Millimeter
Weight0.09 Kilogram
Height106 Millimeter
Width62 Millimeter
Depth62 Millimeter
Weight0.09 Kilogram
Height106 Millimeter
Width62 Millimeter
Depth62 Millimeter
Weight0.09 Kilogram
Height106 Millimeter
Width62 Millimeter
Depth62 Millimeter
Weight0.09 Kilogram
Height106 Millimeter
Width62 Millimeter
Depth62 Millimeter
Weight0.09 Kilogram
Height106 Millimeter
Width62 Millimeter
Depth62 Millimeter
Weight0.09 Kilogram
Height106 Millimeter
Width62 Millimeter
Depth62 Millimeter
Weight0.09 Kilogram
Height106 Millimeter
Width62 Millimeter
Depth62 Millimeter
Weight0.09 Kilogram
Height106 Millimeter
Width62 Millimeter
Depth62 Millimeter
Weight0.09 Kilogram
Height106 Millimeter
Width62 Millimeter
Depth62 Millimeter
Weight0.09 Kilogram
Height106 Millimeter
Width62 Millimeter
Depth62 Millimeter
Weight0.09 Kilogram
Height106 Millimeter
Width62 Millimeter
Depth62 Millimeter
Weight0.09 Kilogram
Height106 Millimeter
Width62 Millimeter
Depth62 Millimeter
Weight0.09 Kilogram
Height106 Millimeter
Width62 Millimeter
Depth62 Millimeter
Weight0.09 Kilogram
Height106 Millimeter
Width62 Millimeter
Depth62 Millimeter
Weight0.09 Kilogram
Height106 Millimeter
Width62 Millimeter
Depth62 Millimeter
Weight0.09 Kilogram
Height106 Millimeter
Width62 Millimeter
Depth62 Millimeter
Weight0.09 Kilogram
Height106 Millimeter
Width62 Millimeter
Depth62 Millimeter

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 HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100860001588316 [Primary]

FDA Product Code

NUHStimulator, Nerve, Transcutaneous, Over-The-Counter

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 Combo2023-10-20 GSM HD Combo Transcutaneous Electrical Nerve Stimulation (TENS): The device is intended for the temporary relief of pain associa
00860001588316 - Pain Warrior2023-10-20TENS: The device is intended to be used 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 and/or normal non-commercial household work activities. Programs 01 to 07, and HAN are TENS programs. NMES: The device is intended to be used to stimulate healthy muscles in order to facilitate and improve muscle performance. Programs 08 to 13 are NMES programs. The device should be used for these purposes
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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