Duns Number:544509582
Device Description: TENS device-EmeTerm 2 generates the electric pulses with highly specific waveforms, freque TENS device-EmeTerm 2 generates the electric pulses with highly specific waveforms, frequency and amplitude to stimulate the median nerve. The accurate pulse signals provide relief through electrical stimulation of the nerves in the patient’s wrist.
Catalog Number
-
Brand Name
EmeTerm 2
Version/Model Number
YF-ZTY-E2
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K220503,K220503
Product Code
GZJ
Product Code Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Public Device Record Key
90b22858-5418-4cbd-a076-229070c52a88
Public Version Date
August 31, 2022
Public Version Number
1
DI Record Publish Date
August 23, 2022
Package DI Number
16971760280111
Quantity per Package
60
Contains DI Package
06971760280114
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |