Duns Number:315304071
Device Description: PIEZOWAVE 2 CONTROL UNIT for all standard indications in orthopedic extracorporeal shockw PIEZOWAVE 2 CONTROL UNIT for all standard indications in orthopedic extracorporeal shockwave therapy (ESWT) and trigger point shockwave therapy (TPST) as well as for acoustic compression therapy, touch screen, color display, control by footswitch, U: 100-240VAC, 50/60Hz, Dim. (wxhxd) 405x226x450mm
Catalog Number
100506US
Brand Name
PIEZOWAVE2
Version/Model Number
100506US
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ISA
Product Code Name
Massager, therapeutic, electric
Public Device Record Key
a7624714-e2d9-4533-a67b-f4ab75ac9715
Public Version Date
February 22, 2022
Public Version Number
1
DI Record Publish Date
February 14, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 587 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1835 |