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
R-C5
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
530f04b6-61ef-4d89-9d62-a7c554b25caf
Public Version Date
February 19, 2021
Public Version Number
2
DI Record Publish Date
September 24, 2020
Package DI Number
10840001700083
Quantity per Package
50
Contains DI Package
00840001700178
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 |