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
10-400-0002
Brand Name
PainShield MD Plus Monnthly 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
-
Product Code
PFW
Product Code Name
Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat
Public Device Record Key
e1433456-498f-4343-b9c0-7e896dbddeee
Public Version Date
May 24, 2022
Public Version Number
1
DI Record Publish Date
May 16, 2022
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 |