Pro Comfort TENS Unit 7188

GUDID 00850632007188

Features: 1.LCD screen 2.2 output ports 3.10-60 minutes adjustable 4.Rechargeable built-in lithium battery Functions: 1.Eliminate body fatigue 2.Relax muscles and joints 3.Improve blood circulation 4.Increase metabolism and prevent many work related symptoms Specifications 1.Power/voltage: 3.7V 2.Massage issuing frequency: 1~110Hz 3.Consumed current: 40mA 4.Status adjustment: 6 kinds of status

HOME AIDE DIAGNOSTICS, 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: 00850632007188
• NIH Device Record Key: 8946747a-51a5-4d4e-ad77-7c4f9b7a4983
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pro Comfort TENS Unit
• Version Model Number: SM9128
• Catalog Number: 7188
• Company DUNS: 783518983
• Company Name: HOME AIDE DIAGNOSTICS, 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 18009150116
• Email: info@homeaide.us
• Phone: 18009150116
• Email: info@homeaide.us
• Phone: 18009150116
• Email: info@homeaide.us
• Phone: 18009150116
• Email: info@homeaide.us
• Phone: 18009150116
• Email: info@homeaide.us
• Phone: 18009150116
• Email: info@homeaide.us
• Phone: 18009150116
• Email: info@homeaide.us
• Phone: 18009150116
• Email: info@homeaide.us
• Phone: 18009150116
• Email: info@homeaide.us
• Phone: 18009150116
• Email: info@homeaide.us
• Phone: 18009150116
• Email: info@homeaide.us
• Phone: 18009150116
• Email: info@homeaide.us
• Phone: 18009150116
• Email: info@homeaide.us
• Phone: 18009150116
• Email: info@homeaide.us
• Phone: 18009150116
• Email: info@homeaide.us
• Phone: 18009150116
• Email: info@homeaide.us
• Phone: 18009150116
• Email: info@homeaide.us
• Phone: 18009150116
• Email: info@homeaide.us
• Phone: 18009150116
• Email: info@homeaide.us
• Phone: 18009150116
• Email: info@homeaide.us
• Phone: 18009150116
• Email: info@homeaide.us
• Phone: 18009150116
• Email: info@homeaide.us
• Phone: 18009150116
• Email: info@homeaide.us
• Phone: 18009150116
• Email: info@homeaide.us
• Phone: 18009150116
• Email: info@homeaide.us
• Phone: 18009150116
• Email: info@homeaide.us
• Phone: 18009150116
• Email: info@homeaide.us
• Phone: 18009150116
• Email: info@homeaide.us
• Phone: 18009150116
• Email: info@homeaide.us

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850632007188 [Primary]
GS1	10850632007185 [Package]; Package: Outer Box [36 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121719

FDA Product Code

• NGX: Stimulator, Muscle, Powered, For Muscle Conditioning

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-10-23
• Device Publish Date: 2017-11-15

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