Duns Number:078497467
Device Description: Tens Device Knee / Elbow 2 in 1For the temporary relief of pain associated with sore and a Tens Device Knee / Elbow 2 in 1For the temporary relief of pain associated with sore and aching muscles
Catalog Number
-
Brand Name
Beurer
Version/Model Number
EM34
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
c52555f3-4005-40b4-8516-5ded050a01d9
Public Version Date
October 23, 2019
Public Version Number
4
DI Record Publish Date
August 21, 2017
Package DI Number
10853879007338
Quantity per Package
4
Contains DI Package
00853879007331
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case Pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 90 |
| U | Unclassified | 2 |