MedX Home Unit - Light Therapy system

GUDID 00628451918189

The MedX Brand Light Therapy home unit is a light therapy system for home use. It is used by the patient to treat a variety of medical conditions such a chronic pain, swelling, inflammation, bruising, wound healing, and much more. The device utilizes an LED light diode cluster that contain a large number of red light diodes. The cluster can be attached to the skin surface with the velcro straps prior to beginning a treatment.

MedX Health Corp

Musculoskeletal/physical therapy laser, professional

• Primary Device ID: 00628451918189
• NIH Device Record Key: 23bb1b26-6f9c-4883-938d-4635e8050885
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MedX Home Unit - Light Therapy system
• Version Model Number: 2031
• Company DUNS: 202128257
• Company Name: MedX Health Corp
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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: 1 905 670 4428
• Email: tobillo@medxhealth.com
• Phone: 1 905 670 4428
• Email: tobillo@medxhealth.com
• Phone: 1 905 670 4428
• Email: tobillo@medxhealth.com
• Phone: 1 905 670 4428
• Email: tobillo@medxhealth.com
• Phone: 1 905 670 4428
• Email: tobillo@medxhealth.com
• Phone: 1 905 670 4428
• Email: tobillo@medxhealth.com
• Phone: 1 905 670 4428
• Email: tobillo@medxhealth.com
• Phone: 1 905 670 4428
• Email: tobillo@medxhealth.com
• Phone: 1 905 670 4428
• Email: tobillo@medxhealth.com
• Phone: 1 905 670 4428
• Email: tobillo@medxhealth.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00628451918165 [Direct Marking]
GS1	00628451918189 [Primary]
GS1	20628451918183 [Package]; Package: shipping carton box [2 Units]; In Commercial Distribution
GS1	30628451918180 [Package]; Package: shipping carton box [3 Units]; In Commercial Distribution
GS1	50628451918184 [Package]; Package: shipping carton box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050022

FDA Product Code

• ILY: Lamp, Infrared, Therapeutic Heating

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 8
• Public Version Date: 2019-05-07
• Device Publish Date: 2016-09-24

Devices Manufactured by MedX Health Corp

• 00628451918189 - MedX Home Unit - Light Therapy system: 2019-05-07The MedX Brand Light Therapy home unit is a light therapy system for home use. It is used by the patient to treat a variety of medical conditions such a chronic pain, swelling, inflammation, bruising, wound healing, and much more. The device utilizes an LED light diode cluster that contain a large number of red light diodes. The cluster can be attached to the skin surface with the velcro straps prior to beginning a treatment.
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