Duns Number:144998551
Device Description: The Model 1620 AC Recharger is a non-sterile external power supply that connects to a powe The Model 1620 AC Recharger is a non-sterile external power supply that connects to a power outlet for use in charging the battery within the Mobile Charger.
Catalog Number
1620
Brand Name
Model 1620 AC Recharger
Version/Model Number
1620
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 01, 2020
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
P130019
Product Code
PIM
Product Code Name
neuromodulator for obesity
Public Device Record Key
f0da9ec9-56fb-49a8-bd08-8b966830699c
Public Version Date
October 14, 2020
Public Version Number
6
DI Record Publish Date
April 17, 2015
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |
| 3 | A medical device with high risk that requires premarket approval | 20 |