Duns Number:102422578
Device Description: Non-thermal radio frequency device for relief of minor aches and pains, relief of muscle s Non-thermal radio frequency device for relief of minor aches and pains, relief of muscle spasms, temporary improvement in local circulation, and temporary reduction in the appearance of cellulite.
Catalog Number
-
Brand Name
Ultimate Contour Mini
Version/Model Number
005-00036
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
K171052,K171052
Product Code
PBX
Product Code Name
Massager, Vacuum, Radio Frequency Induced Heat
Public Device Record Key
832ad484-e4ca-40ba-b313-47117e6bf8bf
Public Version Date
September 16, 2019
Public Version Number
1
DI Record Publish Date
September 06, 2019
Package DI Number
00872320004460
Quantity per Package
1
Contains DI Package
00872320004477
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Kit
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 40 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 51 |