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 ID00628451918189
NIH Device Record Key23bb1b26-6f9c-4883-938d-4635e8050885
Commercial Distribution StatusIn Commercial Distribution
Brand NameMedX Home Unit - Light Therapy system
Version Model Number2031
Company DUNS202128257
Company NameMedX Health Corp
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1 905 670 4428
Emailtobillo@medxhealth.com
Phone1 905 670 4428
Emailtobillo@medxhealth.com
Phone1 905 670 4428
Emailtobillo@medxhealth.com
Phone1 905 670 4428
Emailtobillo@medxhealth.com
Phone1 905 670 4428
Emailtobillo@medxhealth.com
Phone1 905 670 4428
Emailtobillo@medxhealth.com
Phone1 905 670 4428
Emailtobillo@medxhealth.com
Phone1 905 670 4428
Emailtobillo@medxhealth.com
Phone1 905 670 4428
Emailtobillo@medxhealth.com
Phone1 905 670 4428
Emailtobillo@medxhealth.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100628451918165 [Direct Marking]
GS100628451918189 [Primary]
GS120628451918183 [Package]
Package: shipping carton box [2 Units]
In Commercial Distribution
GS130628451918180 [Package]
Package: shipping carton box [3 Units]
In Commercial Distribution
GS150628451918184 [Package]
Package: shipping carton box [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ILYLamp, Infrared, Therapeutic Heating

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number8
Public Version Date2019-05-07
Device Publish Date2016-09-24

Devices Manufactured by MedX Health Corp

00628451918189 - MedX Home Unit - Light Therapy system2019-05-07The 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.
00628451918189 - MedX Home Unit - Light Therapy system2019-05-07 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 m
00628451918226 - MedX Rehab Portable Laser2019-05-07 The MedX Rehab Portable Laser cluster-stand alone, LCS 450, delivers high-quality Low Level Laser Therapy (LLLT). The battery p
00628451918103 - MedX Rehab Console System2019-05-07 The MedX Rehab Laser Console System is a Low-Level Laser therapy system used for the treatment of a variety of medical condition
00628451918288 - MedX Rehab Console2019-05-07 The MedX Rehab Console 1100N controls and powers the MedX tethered laser medical device accessories like the Multi-cluster, teth
00628451918295 - MedX SLD Light Cluster2019-05-07 The MedX SLD Light Cluster accessory, MCT 1001, offers SLD light therapy for broader applications. This accessory can be strapp
00628451918301 - MedX Rehab Tethered Laser2019-05-07 The MedX Rehab Laser cluster-tethered, LCT450, laser medical device accessory is a hand-held Low Level Laser and light Therapy (
00628451918240 - MedX Laser Portable, tethered2019-05-07 The MedX Health portable-tethered laser medical device or LPT201 is part of the kit for MedX Health item numbers #3120 and #312
00628451918165 - MedX Home Console2019-05-07 The MedX Home console or MBM 2030 controls and provides power to MedX SLD cluster MCT 1000. It is the main reference for identif

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.