Duns Number:266031462
Device Description: The PREMIO 10 – Moxa is a medical device for heat therapy. It consists of the following:• 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 arrangementThe 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.
Catalog Number
111237
Brand Name
PREMIO 10 MOXA
Version/Model Number
PREMIO 10
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 22, 2016
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K101267
Product Code
ILY
Product Code Name
Lamp, Infrared, Therapeutic Heating
Public Device Record Key
5abe9e55-6514-435d-9c48-f65a4ed97445
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
September 22, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13 |