Duns Number:080326793
Device Description: The Reusable Patch is a small lightweight treatment patch, which is attached to the user's The Reusable Patch is a small lightweight treatment patch, which is attached to the user's skin at the location of the pain. The patch is energized with a signal from the PainShield's driver and creates mechanical vibrations via piezo-electric element. After the use patch should be covered with its original liner till next use.
Catalog Number
-
Brand Name
Reusable Patch
Version/Model Number
PRP-20
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
PFW
Product Code Name
Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat
Public Device Record Key
581f085c-7133-4230-be4b-fedc897b2c02
Public Version Date
August 05, 2019
Public Version Number
1
DI Record Publish Date
July 28, 2019
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. | 7 |