Duns Number:135741127
Device Description: (1) - Electronic Digital Massager with TENS & EMS Functions -12 Modes of Therapy - 2 Separ (1) - Electronic Digital Massager with TENS & EMS Functions -12 Modes of Therapy - 2 Separate Channels- Includes: device, lead wires, USB Type Charger Included and (1) pack of electrodes, instruction manual
Catalog Number
PM-745
Brand Name
PM-745
Version/Model Number
PM-745
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
-
Product Code
IPF
Product Code Name
Stimulator, Muscle, Powered
Public Device Record Key
e66ee5af-3ace-4c49-8e0e-1c98b5243cc3
Public Version Date
February 19, 2021
Public Version Number
3
DI Record Publish Date
June 29, 2017
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |