Duns Number:544587118
Device Description: It is used for temporary relief of pain associated with sore and aching muscles in the sho 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 to6 strain from exercise or normal household work activities.
Catalog Number
-
Brand Name
ROOVJOY
Version/Model Number
TENS3500
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
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GZL
Product Code Name
Electrode, Depth
Public Device Record Key
4046dfae-2858-4ce6-899a-17ff5092c369
Public Version Date
August 19, 2022
Public Version Number
2
DI Record Publish Date
May 18, 2022
Package DI Number
10840001700151
Quantity per Package
32
Contains DI Package
00840001700246
Package Discontinue Date
-
Package Status
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. | 23 |