Duns Number:531958689
Device Description: The EndyMed Contour Handpiece is intended for the treatment of the following medical condi The EndyMed Contour Handpiece is intended for the treatment of the following medical conditions; using the Contour applicator for delivery of non-thermal RF combined with massage: • Relief of minor muscle aches and pain, relief of muscle spasm • Temporary improvement of local blood circulation • Temporary reduction in the appearance of cellulite.
Catalog Number
ND_PRD00180
Brand Name
EndyMed PRO Contour Handpiece
Version/Model Number
Countour Handpiece
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
-
Product Code
PBX
Product Code Name
Massager, Vacuum, Radio Frequency Induced Heat
Public Device Record Key
6827e4c0-b997-48ae-98a0-ca6a90d9a01c
Public Version Date
March 21, 2019
Public Version Number
2
DI Record Publish Date
December 31, 2018
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 32 |