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 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 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 ID	B736465731
NIH Device Record Key	09a7475f-43b2-4fcc-bf97-9a2a4ffe253f
Commercial Distribution Status	In Commercial Distribution
Brand Name	SwallowStim Classic
Version Model Number	01GS25
Catalog Number	01GS25
Company DUNS	793161472
Company Name	SPECTRAMED, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	1-800-643-1917
Email	info@spectramedonline.com
Phone	1-800-643-1917
Email	info@spectramedonline.com
Phone	1-800-643-1917
Email	info@spectramedonline.com
Phone	1-800-643-1917
Email	info@spectramedonline.com
Phone	1-800-643-1917
Email	info@spectramedonline.com
Phone	1-800-643-1917
Email	info@spectramedonline.com
Phone	1-800-643-1917
Email	info@spectramedonline.com
Phone	1-800-643-1917
Email	info@spectramedonline.com
Phone	1-800-643-1917
Email	info@spectramedonline.com
Phone	1-800-643-1917
Email	info@spectramedonline.com
Phone	1-800-643-1917
Email	info@spectramedonline.com
Phone	1-800-643-1917
Email	info@spectramedonline.com
Phone	1-800-643-1917
Email	info@spectramedonline.com
Phone	1-800-643-1917
Email	info@spectramedonline.com
Phone	1-800-643-1917
Email	info@spectramedonline.com
Phone	1-800-643-1917
Email	info@spectramedonline.com
Phone	1-800-643-1917
Email	info@spectramedonline.com
Phone	1-800-643-1917
Email	info@spectramedonline.com
Phone	1-800-643-1917
Email	info@spectramedonline.com
Phone	1-800-643-1917
Email	info@spectramedonline.com
Phone	1-800-643-1917
Email	info@spectramedonline.com
Phone	1-800-643-1917
Email	info@spectramedonline.com
Phone	1-800-643-1917
Email	info@spectramedonline.com
Phone	1-800-643-1917
Email	info@spectramedonline.com
Phone	1-800-643-1917
Email	info@spectramedonline.com
Phone	1-800-643-1917
Email	info@spectramedonline.com
Phone	1-800-643-1917
Email	info@spectramedonline.com
Phone	1-800-643-1917
Email	info@spectramedonline.com
Phone	1-800-643-1917
Email	info@spectramedonline.com

Device Dimensions

Depth	1.1 Inch
Weight	0.46875 Pound
Width	2.6 Inch
Length	5 Inch
Depth	1.1 Inch
Weight	0.46875 Pound
Width	2.6 Inch
Length	5 Inch
Depth	1.1 Inch
Weight	0.46875 Pound
Width	2.6 Inch
Length	5 Inch
Depth	1.1 Inch
Weight	0.46875 Pound
Width	2.6 Inch
Length	5 Inch
Depth	1.1 Inch
Weight	0.46875 Pound
Width	2.6 Inch
Length	5 Inch
Depth	1.1 Inch
Weight	0.46875 Pound
Width	2.6 Inch
Length	5 Inch
Depth	1.1 Inch
Weight	0.46875 Pound
Width	2.6 Inch
Length	5 Inch
Depth	1.1 Inch
Weight	0.46875 Pound
Width	2.6 Inch
Length	5 Inch
Depth	1.1 Inch
Weight	0.46875 Pound
Width	2.6 Inch
Length	5 Inch
Depth	1.1 Inch
Weight	0.46875 Pound
Width	2.6 Inch
Length	5 Inch
Depth	1.1 Inch
Weight	0.46875 Pound
Width	2.6 Inch
Length	5 Inch
Depth	1.1 Inch
Weight	0.46875 Pound
Width	2.6 Inch
Length	5 Inch
Depth	1.1 Inch
Weight	0.46875 Pound
Width	2.6 Inch
Length	5 Inch
Depth	1.1 Inch
Weight	0.46875 Pound
Width	2.6 Inch
Length	5 Inch
Depth	1.1 Inch
Weight	0.46875 Pound
Width	2.6 Inch
Length	5 Inch
Depth	1.1 Inch
Weight	0.46875 Pound
Width	2.6 Inch
Length	5 Inch
Depth	1.1 Inch
Weight	0.46875 Pound
Width	2.6 Inch
Length	5 Inch
Depth	1.1 Inch
Weight	0.46875 Pound
Width	2.6 Inch
Length	5 Inch
Depth	1.1 Inch
Weight	0.46875 Pound
Width	2.6 Inch
Length	5 Inch
Depth	1.1 Inch
Weight	0.46875 Pound
Width	2.6 Inch
Length	5 Inch
Depth	1.1 Inch
Weight	0.46875 Pound
Width	2.6 Inch
Length	5 Inch
Depth	1.1 Inch
Weight	0.46875 Pound
Width	2.6 Inch
Length	5 Inch
Depth	1.1 Inch
Weight	0.46875 Pound
Width	2.6 Inch
Length	5 Inch
Depth	1.1 Inch
Weight	0.46875 Pound
Width	2.6 Inch
Length	5 Inch
Depth	1.1 Inch
Weight	0.46875 Pound
Width	2.6 Inch
Length	5 Inch
Depth	1.1 Inch
Weight	0.46875 Pound
Width	2.6 Inch
Length	5 Inch
Depth	1.1 Inch
Weight	0.46875 Pound
Width	2.6 Inch
Length	5 Inch
Depth	1.1 Inch
Weight	0.46875 Pound
Width	2.6 Inch
Length	5 Inch
Depth	1.1 Inch

Operating and Storage Conditions

Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -6 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 101.3 KiloPascal
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -6 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 101.3 KiloPascal
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -6 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 101.3 KiloPascal
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -6 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 101.3 KiloPascal
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -6 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 101.3 KiloPascal
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -6 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 101.3 KiloPascal
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -6 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 101.3 KiloPascal
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -6 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 101.3 KiloPascal
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -6 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 101.3 KiloPascal
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -6 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 101.3 KiloPascal
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -6 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 101.3 KiloPascal
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -6 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 101.3 KiloPascal
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -6 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 101.3 KiloPascal
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -6 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 101.3 KiloPascal
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -6 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 101.3 KiloPascal
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -6 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 101.3 KiloPascal
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -6 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 101.3 KiloPascal
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -6 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 101.3 KiloPascal
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -6 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 101.3 KiloPascal
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -6 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 101.3 KiloPascal
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -6 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 101.3 KiloPascal
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -6 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 101.3 KiloPascal
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -6 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 101.3 KiloPascal
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -6 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 101.3 KiloPascal
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -6 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 101.3 KiloPascal
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -6 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 101.3 KiloPascal
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -6 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 101.3 KiloPascal
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -6 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 101.3 KiloPascal
Storage Environment Humidity	Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B736465731 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K120922

FDA Product Code

IPF	Stimulator, Muscle, Powered

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2019-10-23
Device Publish Date	2019-07-15

Devices Manufactured by SPECTRAMED, INC.

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