Duns Number:827221698
Device Description: InTENSity at Home OTC TENS device with 12 preset programs and 100 Intensity levels
Catalog Number
-
Brand Name
InTENSity at Home TENS Device
Version/Model Number
E200-6R
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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"
Yes
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
cf23c450-9b12-420c-9b3c-1805d3b7f74e
Public Version Date
May 18, 2021
Public Version Number
1
DI Record Publish Date
May 10, 2021
Package DI Number
30092237619590
Quantity per Package
6
Contains DI Package
00092237619599
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 62 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 273 |
| U | Unclassified | 2 |