Duns Number:544587118
Device Description: TENS mode It is used for temporary relief of pain associated with sore and aching muscles TENS mode It is used for temporary relief of pain associated with sore and aching muscles in the shoulder, low back, joint, hip, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
Catalog Number
-
Brand Name
ROOVJOY
Version/Model Number
R-T1
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 28, 2020
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
Yes
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
K180956,K180956
Product Code
NUH
Product Code Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
Public Device Record Key
067432f0-9216-4392-ae80-5c13d9873249
Public Version Date
August 19, 2022
Public Version Number
9
DI Record Publish Date
July 15, 2018
Package DI Number
18400017010013
Quantity per Package
50
Contains DI Package
00840001701014
Package Discontinue Date
May 28, 2020
Package Status
Not in Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |