Brand Name | MAX POWER RELIEF TENS THERAPY |
Type of Device | TENS |
Manufacturer (Section D) |
OMRON HEALTHCARE CO., LTD |
53 kunotsubo |
terado-cho |
muko-city, kyoto 61700 02 |
JA 6170002 |
|
Manufacturer (Section G) |
OMRON HEALTHCARE CO., LTD |
53 kunotsubo |
terado-cho |
muko-city, kyoro 61700 02 |
JA
6170002
|
|
Manufacturer Contact |
tomoji
zukawa
|
53 kunotsubo |
terado-cho |
muko-city, kyoto 61700-02
|
JA
6170002
|
|
MDR Report Key | 17770325 |
MDR Text Key | 323679332 |
Report Number | 8030245-2023-00006 |
Device Sequence Number | 1 |
Product Code |
NUH
|
UDI-Device Identifier | 00073796635008 |
UDI-Public | (01)00073796635008 |
Combination Product (y/n) | Y |
Reporter Country Code | US |
PMA/PMN Number | K182120 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Consumer,Company Representative,Distributor |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
12/23/2023 |
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 Operator |
Lay User/Patient
|
Device Model Number | PM500 |
Device Catalogue Number | PM500 |
Device Lot Number | 201910U |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 09/18/2023 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 12/22/2023
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/15/2019 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Age | 37 YR |
Patient Sex | Male |
|
|