Brand Name | HEALTH SMART WATCH |
Type of Device | INSTRUMENT, GLUCOSE, NONINVASIVE TECHNOLOGY |
Manufacturer (Section D) |
SHEN ZHEN BALE ELECTRONICS CO.,LTD |
wanzhongcheng clothing wholesale market xinniu community, minzhi street |
room b335 |
longhua district, shenzhen |
CH |
|
MDR Report Key | 18816611 |
MDR Text Key | 336822080 |
Report Number | MW5152227 |
Device Sequence Number | 1 |
Product Code |
NCT
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
02/22/2024 |
2 Devices were Involved in the Event: |
1
2
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Model Number | EP03 |
Was Device Available for Evaluation? |
Yes
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 02/29/2024 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 03/15/2024
|
Patient Sequence Number | 1 |
Treatment | LIPITOR.; METFORMIN.; ONE A DAY VITAMINS.; VALSARTAN. |
Patient Outcome(s) |
Other;
|
Patient Sex | Female |
Patient Weight | 50 KG |
Patient Ethnicity | Non Hispanic |
Patient Race | Asian |
|
|