AccessGUDID - DEVICE: MedX Home Unit - Light Therapy system (00628451918189)

GUDID

Device Identifier (DI) Information

Brand Name: MedX Home Unit - Light Therapy system
Version or Model: 2031
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MedX Health Corp

Primary DI Number: 00628451918189
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 202128257 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60409	Musculoskeletal/physical therapy laser, professional	An electrically-powered diode laser intended to provide non-surgical laser therapy [e.g., infrared phototherapy, low-level laser therapy (LLLT)] for localized treatment of musculoskeletal conditions (e.g., muscle/joint pain, sports injury), improvement of local blood circulation in the treated areas to facilitate healing, or for non-needle acupuncture. It typically consists of a control unit which may be mounted on a mobile trolley, a foot-switch, and a connected applicator/beam guide designed for intra-orifice (e.g., intravaginal) or transcutaneous delivery of visible red/infrared laser light energy/heat. It is intended to be operated exclusively by a healthcare professional.	Active	false

FDA Product Code

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Product Code	Product Code Name
ILY	Lamp, Infrared, Therapeutic Heating

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K050022	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 23bb1b26-6f9c-4883-938d-4635e8050885
Public Version Date: December 08, 2022
Public Version Number: 9
DI Record Publish Date: September 24, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
50628451918184	5	00628451918189	In Commercial Distribution	shipping carton box
30628451918180	3	00628451918189	In Commercial Distribution	shipping carton box
20628451918183	2	00628451918189	In Commercial Distribution	shipping carton box