Duns Number:526951168
Device Description: TENS stands for Transcutaneous Electrical Nerve Stimulation. The TRi-WAVE TENS system is TENS stands for Transcutaneous Electrical Nerve Stimulation. The TRi-WAVE TENS system is used to provide symptomatic pain relief for chronic, acute or post-operative pain.EMS stands for Electrical Neuromuscular Stimulator. The TRi-WAVE EMS system is indicated for:• Relaxation of muscle spasm;• Increasing local blood circulation and muscle re-education;• Prevention or retardation of disuse atrophy;• Prevention of venous thrombosis of the calf muscles immediately after surgery;• Maintaining or increasing range of motion.IF stands for Interferential Stimulation. The TRi-WAVE IF system is indicated for:• Symptomatic relief of chronic intractable pain.
Catalog Number
-
Brand Name
TRi-WAVE
Version/Model Number
TRi-WAVE
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
485c8c2c-3301-4e01-b70a-a3edab039db4
Public Version Date
November 23, 2021
Public Version Number
1
DI Record Publish Date
November 15, 2021
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 |