Duns Number:945748965
Device Description: Electrical Muscle Stimulator intended to stimulate healthy muscles in order to improve or Electrical Muscle Stimulator intended to stimulate healthy muscles in order to improve or facilitate muscle performance.
Catalog Number
-
Brand Name
ARP POV SPORT
Version/Model Number
PRS
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K093999
Product Code
NGX
Product Code Name
Stimulator, Muscle, Powered, For Muscle Conditioning
Public Device Record Key
9168774e-30e4-402b-9bec-3a9516ffb610
Public Version Date
February 19, 2021
Public Version Number
7
DI Record Publish Date
August 23, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |