Duns Number:080326793
Device Description: PainShield MD applies ultrasound energy through a treatment patch that is placed at, or cl PainShield MD applies ultrasound energy through a treatment patch that is placed at, or close to, the center of the painful area. The user may feel minor warmth at the treatment patch site during the treatment period. PainShield MD should be used under the prescription of a physician or physical therapist. PainShield MD is comprised of two elements: a treatment patch that contains the transducer, which delivers ultrasound waves and a portable battery-operated driver.
Catalog Number
-
Brand Name
PainShield
Version/Model Number
PS-30
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
K081075
Product Code
PFW
Product Code Name
Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat
Public Device Record Key
4d0eca5a-9e89-4b9d-afbc-2f7a86be2fdf
Public Version Date
November 17, 2020
Public Version Number
2
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 |