Guardian Unity 01GS90

GUDID B73643211

2-channel neuromuscular stimulation device. Handheld, Portable and battery powered by 4 AA Alkaline batteries. Maximum device output 90mA with 7 pre-set programs

SPECTRAMED, INC.

Physical therapy transcutaneous neuromuscular electrical stimulation system
Primary Device IDB73643211
NIH Device Record Key773fe51f-005d-401d-abde-ba7f88116a77
Commercial Distribution StatusIn Commercial Distribution
Brand NameGuardian Unity
Version Model Number01GS90
Catalog Number01GS90
Company DUNS793161472
Company NameSPECTRAMED, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-643-1917
Emailinfo@spectramedonline.com
Phone1-800-643-1917
Emailinfo@spectramedonline.com
Phone1-800-643-1917
Emailinfo@spectramedonline.com
Phone1-800-643-1917
Emailinfo@spectramedonline.com
Phone1-800-643-1917
Emailinfo@spectramedonline.com
Phone1-800-643-1917
Emailinfo@spectramedonline.com
Phone1-800-643-1917
Emailinfo@spectramedonline.com
Phone1-800-643-1917
Emailinfo@spectramedonline.com
Phone1-800-643-1917
Emailinfo@spectramedonline.com
Phone1-800-643-1917
Emailinfo@spectramedonline.com
Phone1-800-643-1917
Emailinfo@spectramedonline.com
Phone1-800-643-1917
Emailinfo@spectramedonline.com
Phone1-800-643-1917
Emailinfo@spectramedonline.com
Phone1-800-643-1917
Emailinfo@spectramedonline.com
Phone1-800-643-1917
Emailinfo@spectramedonline.com
Phone1-800-643-1917
Emailinfo@spectramedonline.com
Phone1-800-643-1917
Emailinfo@spectramedonline.com
Phone1-800-643-1917
Emailinfo@spectramedonline.com
Phone1-800-643-1917
Emailinfo@spectramedonline.com
Phone1-800-643-1917
Emailinfo@spectramedonline.com
Phone1-800-643-1917
Emailinfo@spectramedonline.com
Phone1-800-643-1917
Emailinfo@spectramedonline.com
Phone1-800-643-1917
Emailinfo@spectramedonline.com
Phone1-800-643-1917
Emailinfo@spectramedonline.com
Phone1-800-643-1917
Emailinfo@spectramedonline.com
Phone1-800-643-1917
Emailinfo@spectramedonline.com
Phone1-800-643-1917
Emailinfo@spectramedonline.com
Phone1-800-643-1917
Emailinfo@spectramedonline.com
Phone1-800-643-1917
Emailinfo@spectramedonline.com

Device Dimensions

Weight0.46875 Pound
Depth1.1 Inch
Length5 Inch
Width2.6 Inch
Weight0.46875 Pound
Depth1.1 Inch
Length5 Inch
Width2.6 Inch
Weight0.46875 Pound
Depth1.1 Inch
Length5 Inch
Width2.6 Inch
Weight0.46875 Pound
Depth1.1 Inch
Length5 Inch
Width2.6 Inch
Weight0.46875 Pound
Depth1.1 Inch
Length5 Inch
Width2.6 Inch
Weight0.46875 Pound
Depth1.1 Inch
Length5 Inch
Width2.6 Inch
Weight0.46875 Pound
Depth1.1 Inch
Length5 Inch
Width2.6 Inch
Weight0.46875 Pound
Depth1.1 Inch
Length5 Inch
Width2.6 Inch
Weight0.46875 Pound
Depth1.1 Inch
Length5 Inch
Width2.6 Inch
Weight0.46875 Pound
Depth1.1 Inch
Length5 Inch
Width2.6 Inch
Weight0.46875 Pound
Depth1.1 Inch
Length5 Inch
Width2.6 Inch
Weight0.46875 Pound
Depth1.1 Inch
Length5 Inch
Width2.6 Inch
Weight0.46875 Pound
Depth1.1 Inch
Length5 Inch
Width2.6 Inch
Weight0.46875 Pound
Depth1.1 Inch
Length5 Inch
Width2.6 Inch
Weight0.46875 Pound
Depth1.1 Inch
Length5 Inch
Width2.6 Inch
Weight0.46875 Pound
Depth1.1 Inch
Length5 Inch
Width2.6 Inch
Weight0.46875 Pound
Depth1.1 Inch
Length5 Inch
Width2.6 Inch
Weight0.46875 Pound
Depth1.1 Inch
Length5 Inch
Width2.6 Inch
Weight0.46875 Pound
Depth1.1 Inch
Length5 Inch
Width2.6 Inch
Weight0.46875 Pound
Depth1.1 Inch
Length5 Inch
Width2.6 Inch
Weight0.46875 Pound
Depth1.1 Inch
Length5 Inch
Width2.6 Inch
Weight0.46875 Pound
Depth1.1 Inch
Length5 Inch
Width2.6 Inch
Weight0.46875 Pound
Depth1.1 Inch
Length5 Inch
Width2.6 Inch
Weight0.46875 Pound
Depth1.1 Inch
Length5 Inch
Width2.6 Inch
Weight0.46875 Pound
Depth1.1 Inch
Length5 Inch
Width2.6 Inch
Weight0.46875 Pound
Depth1.1 Inch
Length5 Inch
Width2.6 Inch
Weight0.46875 Pound
Depth1.1 Inch
Length5 Inch
Width2.6 Inch
Weight0.46875 Pound
Depth1.1 Inch
Length5 Inch
Width2.6 Inch
Weight0.46875 Pound

Operating and Storage Conditions

Storage Environment TemperatureBetween -6 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween -6 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween -6 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween -6 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween -6 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween -6 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween -6 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween -6 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween -6 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween -6 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween -6 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween -6 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween -6 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween -6 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween -6 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween -6 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween -6 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween -6 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween -6 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween -6 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween -6 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween -6 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween -6 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween -6 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween -6 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween -6 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween -6 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween -6 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 101.3 KiloPascal
Storage Environment TemperatureBetween -6 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB73643211 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IPFStimulator, Muscle, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-10-23
Device Publish Date2019-04-01

Devices Manufactured by SPECTRAMED, INC.

B736465731 - SwallowStim Classic2019-10-23 2-channel neuromuscular stimulation device. Handheld, Portable and battery powered by 4 AA Alkaline batteries. Maximum device ou
B73643211 - Guardian Unity2019-10-232-channel neuromuscular stimulation device. Handheld, Portable and battery powered by 4 AA Alkaline batteries. Maximum device output 90mA with 7 pre-set programs
B73643211 - Guardian Unity2019-10-23 2-channel neuromuscular stimulation device. Handheld, Portable and battery powered by 4 AA Alkaline batteries. Maximum device ou
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