MedX Rehab Tethered Laser

GUDID 00628451918301

The MedX Rehab Laser cluster-tethered, LCT450, laser medical device accessory is a hand-held Low Level Laser and light Therapy (LLLT) device for use to treat a wide variety of medical conditions. It is also used for treating deeper tissue conditions. This accessory contains three SLD near-infrared laser light diodes for therapeutic applications and a visible LED guide light. It is part of the kit for MedX Health Items #3114, #3116. LCT 450 is controlled and powered by MedX Rehab console 1100N. This registration shows its UDI for direct marking and primary packaging when shipped as a particular item and not as part of a kit.

MedX Health Corp

Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional Musculoskeletal/physical therapy laser, professional
Primary Device ID00628451918301
NIH Device Record Key7bc1182e-d1a2-4b74-9f35-41648b74bd14
Commercial Distribution StatusIn Commercial Distribution
Brand NameMedX Rehab Tethered Laser
Version Model Number450
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 Kitfalse
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 -4 Degrees Fahrenheit and 149 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 -4 Degrees Fahrenheit and 149 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 -4 Degrees Fahrenheit and 149 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 -4 Degrees Fahrenheit and 149 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 -4 Degrees Fahrenheit and 149 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 -4 Degrees Fahrenheit and 149 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 -4 Degrees Fahrenheit and 149 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 -4 Degrees Fahrenheit and 149 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
GS100628451918134 [Direct Marking]
GS100628451918301 [Primary]

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 Number7
Public Version Date2019-05-07
Device Publish Date2016-09-24

Devices Manufactured by MedX Health Corp

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00628451918301 - MedX Rehab Tethered Laser2019-05-07The MedX Rehab Laser cluster-tethered, LCT450, laser medical device accessory is a hand-held Low Level Laser and light Therapy (LLLT) device for use to treat a wide variety of medical conditions. It is also used for treating deeper tissue conditions. This accessory contains three SLD near-infrared laser light diodes for therapeutic applications and a visible LED guide light. It is part of the kit for MedX Health Items #3114, #3116. LCT 450 is controlled and powered by MedX Rehab console 1100N. This registration shows its UDI for direct marking and primary packaging when shipped as a particular item and not as part of a kit.
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