Duns Number:867673159
Device Description: Personal CareExercise Peddler Product Description: Enfer Exercise Peddler,SilverVein,2/cs
Catalog Number
-
Brand Name
Drive
Version/Model Number
E-10270SV-2
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ION
Product Code Name
EXERCISER, NON-MEASURING
Public Device Record Key
b73a9853-acde-4772-98e9-76011751452e
Public Version Date
August 09, 2021
Public Version Number
2
DI Record Publish Date
June 21, 2019
Package DI Number
50822383286360
Quantity per Package
2
Contains DI Package
00822383286365
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3783 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 832 |