Duns Number:481967776
Device Description: The MASTERPULS® ONE is a compressed air-operated ballistic pressure wave generator.
Catalog Number
-
Brand Name
MASTERPULS®
Version/Model Number
ONE
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
K173692
Product Code
ISA
Product Code Name
Massager, Therapeutic, Electric
Public Device Record Key
05d4dce4-3b7f-483c-9858-ff43d0ff1003
Public Version Date
August 20, 2020
Public Version Number
2
DI Record Publish Date
September 16, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 18 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 11 |
| 3 | A medical device with high risk that requires premarket approval | 7 |