Duns Number:526951168
Device Description: MKIII is an EMS (Electrical Neuromuscular Stimulator), which is indicated for:1. Relaxatio MKIII is an EMS (Electrical Neuromuscular Stimulator), which is indicated for:1. Relaxation of muscle spasm; 2 Increasing local blood circulation and muscle re-education; 3. Prevention or retardation of disuse atrophy; 4. Prevention of venous thrombosis of the calf muscles immediately after surgery; 5.Maintaining or increasing range of motion.
Catalog Number
-
Brand Name
MKIII
Version/Model Number
MKIII
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
GZJ
Product Code Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Public Device Record Key
2538a87b-1258-4710-ae09-e524f74a80c3
Public Version Date
February 19, 2021
Public Version Number
8
DI Record Publish Date
December 31, 2016
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. | 25 |