Brand Name | FISHER WALLACE CRANIAL NEUROSTIMULATOR |
Type of Device | CRANIAL NEUROSTIMULATOR |
Manufacturer (Section D) |
FISHER WALLACE LABS |
630 flushing ave |
brooklyn NY 11206 |
|
Manufacturer (Section G) |
NANJING WATT ELECTRIC MOTOR CO. LTD., |
no. 2 yihu road, lishui |
economic development zone |
nanjing, jiangsu 21120 0 |
CH
211200
|
|
Manufacturer Contact |
gordon
levites
|
630 flushing ave |
brooklyn, NY 11206
|
8006924380
|
|
MDR Report Key | 16862024 |
MDR Text Key | 314497674 |
Report Number | 3006258094-2023-00038 |
Device Sequence Number | 1 |
Product Code |
QJQ
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K903654 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Study,Consumer |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
11/11/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Model Number | FW-100 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 05/03/2023 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Removal/Correction Number | RES 91982 |
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Sex | Male |
|
|