Duns Number:504712829
Device Description: The PROFILE EMS is a symmetrical biphasic neuromuscular electronic stimulator intended for The PROFILE EMS is a symmetrical biphasic neuromuscular electronic stimulator intended for medical purposes, which repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area. It is indicated for the following:- Prevention or retardation of muscle disuse atrophy; - Relaxation of muscle spasm;- Muscle reeducation; - Maintaining and increasing the range of motion; - Increasing local blood circulation;- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
Catalog Number
-
Brand Name
PROFILE EMS
Version/Model Number
EM-PROFILE_EMS
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
eb2ba8e6-657d-449e-9eec-2e04fd559b7f
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
February 12, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |