Duns Number:544559614
Device Description: To be used for temporary relief of pain associated with sore and aching muscles in the sho To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities.
Catalog Number
-
Brand Name
AUVON
Version/Model Number
PL-029GA
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
-
Product Code
NUH
Product Code Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
Public Device Record Key
9189e6b0-6074-4d81-a1a1-0a156fe522c3
Public Version Date
October 23, 2019
Public Version Number
3
DI Record Publish Date
March 20, 2018
Package DI Number
26971292002929
Quantity per Package
42
Contains DI Package
06971292002901
Package Discontinue Date
March 20, 2018
Package Status
Not in Commercial Distribution
Package Type
canton box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 99 |