Duns Number:144998551
Device Description: The Model 2402 Mobile Charger (MC) is a non-sterile external component that is powered by The Model 2402 Mobile Charger (MC) is a non-sterile external component that is powered by a rechargeable, lithium-ion battery. The MC charges the Rechargeable Neuroregulator (RNR) when connected to a Transmit Coil positioned over the RNR. The MC also provides communication between the Clinician Programmer and RNR to allow up and down loading of data, display battery charge levels, indicate proper positioning of the Transmit Coil, alert patient to fault conditions, and allow for inactivation of therapy and turning off the RNR if needed.
Catalog Number
2402
Brand Name
Model 2402 Maestro Mobile Charger
Version/Model Number
2402
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
d575342c-8fe1-4970-9f8d-c2cc6e7233ab
Public Version Date
October 14, 2020
Public Version Number
5
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 |