AccessGUDID - DEVICE: PREMIO 10 MOXA (03760262493107)

GUDID

Device Identifier (DI) Information

Brand Name: PREMIO 10 MOXA
Version or Model: PREMIO 10
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 111237
Company Name: SEDATELEC

Primary DI Number: 03760262493107
Issuing Agency: GS1
Commercial Distribution End Date: September 22, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 266031462 *Terms of Use

Device Description: The PREMIO 10 – Moxa is a medical device for heat therapy. It consists of the following: • A handpiece with a Power Supply (110-240V~ /50-60Hz) • A tip concentrator • An user manual • A cover of arrangement The PREMIO 10 - MOXA is a non-invasive infrared lamp intended to provide topical heating. The PREMIO 10 - MOXA is indicated for temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.

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:	No
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?
35147	Musculoskeletal infrared phototherapy unit, non-wearable	An electrically-powered device intended for use in the home or clinical setting to provide a source of infrared (IR) heat for localized treatment of musculoskeletal pain/injury (e.g., muscle pain, sports injury, rheumatism) and to improve blood circulation in the treated areas to facilitate healing. It may be available in a variety of forms however it is not intended to be worn on the body.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K101267	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
Handling Environment Atmospheric Pressure: between 1 and 2 KiloPascal
Handling Environment Humidity: between 0 and 70 Percent (%) Relative Humidity
Handling Environment Temperature: between 0 and 25 Degrees Celsius
Storage Environment Humidity: between 0 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5abe9e55-6514-435d-9c48-f65a4ed97445
Public Version Date: April 18, 2025
Public Version Number: 5
DI Record Publish Date: September 22, 2016