Duns Number:315304071
Device Description: THERAPY SOURCE F7 G3 for WellWave, PiezoWave, PiezoWave2, point focused, total energy (12 THERAPY SOURCE F7 G3 for WellWave, PiezoWave, PiezoWave2, point focused, total energy (12mm) 13,6mJ, total energy flow density 0,048 - 0,403mJ/mm², peak pressure (p+) 7,8 - 49,0MPa, penetration max. 30mm, focal length fx,y/fz (-6dB) min. 3,6x18,0mm, max. 1,2x5,6mm
Catalog Number
80601
Brand Name
NA
Version/Model Number
80601
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
23a3f723-c301-4a0a-bfdf-5f3969a4fbfc
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 |