Duns Number:112117283
Device Description: Aleve Direct Therapy TENS Device delivers stimulating pulses to the site of pain using th Aleve Direct Therapy TENS Device delivers stimulating pulses to the site of pain using the same technology found in doctors, physical therapists, and chiropractor's offices. Aleve Direct Therapy TENS Device is indicated for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities. The kit contains a device, 2 pairs of gel pads, 2-AAA batteries, 1 Phillips head screwdriver and a wireless remote control.
Catalog Number
-
Brand Name
Aleve
Version/Model Number
1613538
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 07, 2019
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
9ef83ab7-8a4d-4c50-80fc-7792855cb39c
Public Version Date
October 23, 2019
Public Version Number
4
DI Record Publish Date
September 01, 2017
Package DI Number
10016500574054
Quantity per Package
6
Contains DI Package
00016500574057
Package Discontinue Date
June 07, 2019
Package Status
Not 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 |