SwallowStim Classic 01GS25

GUDID B736465731

2-channel neuromuscular stimulation device. Handheld, Portable and battery powered by 4 AA Alkaline batteries. Maximum device output 50mA peak to peak with 1 pre-set program

SPECTRAMED, INC.

Physical therapy transcutaneous neuromuscular electrical stimulation system
Primary Device IDB736465731
NIH Device Record Key09a7475f-43b2-4fcc-bf97-9a2a4ffe253f
Commercial Distribution StatusIn Commercial Distribution
Brand NameSwallowStim Classic
Version Model Number01GS25
Catalog Number01GS25
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

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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB736465731 [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 Number2
Public Version Date2019-10-23
Device Publish Date2019-07-15

Devices Manufactured by SPECTRAMED, INC.

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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 Unity2019-10-23 2-channel neuromuscular stimulation device. Handheld, Portable and battery powered by 4 AA Alkaline batteries. Maximum device ou
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