Duns Number:080326793
Device Description: The Monthly kit includes a treatment actuator that incorporates an ultrasonic transducer a The Monthly kit includes a treatment actuator that incorporates an ultrasonic transducer and connects to the driver with a cable.The transducer is applied to the patient skin using single use adhesive pads. After connecting to the driver and activation, the actuator converts electric signals to ultrasound therapeutic waves.
Catalog Number
10-100-0013
Brand Name
PainShield Monthly Kit
Version/Model Number
3.0
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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"
Yes
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
7fad6d82-8c74-4092-afec-1537b94cb031
Public Version Date
December 30, 2020
Public Version Number
1
DI Record Publish Date
December 22, 2020
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 |