Duns Number:532396673
Device Description: Radiofrequency Applicator to be used with Formatk Systems Ltd supporting systems for minor Radiofrequency Applicator to be used with Formatk Systems Ltd supporting systems for minor muscle aches and pain treatments
Catalog Number
FS10011
Brand Name
ST
Version/Model Number
FS10011
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
K160195
Product Code
PBX
Product Code Name
Massager, Vacuum, Radio Frequency Induced Heat
Public Device Record Key
0a7abea0-d7a5-473d-a9e6-f1f4266ddf9d
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 18, 2017
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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 28 |