Duns Number:569403736
Device Description: TENS One is a TENS device which is commonly used to provide relief from pain associated wi TENS One is a TENS device which is commonly used to provide relief from pain associated with sore or aching muscles of the lowerback, arms, or legs due to strain from exercise or normal household and work activities.It has 3 treatment modes and is designed to be easy to use, with analog-style rotary intensity controls, digital mode selection and display, open circuit detection and keypad cover. It uses standard AA batteries and self-adhesive electrode pads. Garment glove and sock electrodes are available as optional extras.
Catalog Number
K-TENSONE
Brand Name
Tenscare
Version/Model Number
TENS One
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
-
Product Code
NUH
Product Code Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
Public Device Record Key
9bea6bcf-26ec-4970-bb20-2c9f1c425652
Public Version Date
October 23, 2019
Public Version Number
2
DI Record Publish Date
August 05, 2019
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. | 7 |