Wellell Inc.
6 inspections · 2 clearances · aggregated across 3 source records
Scorecard
Events per device across the 207-device portfolio, trailing 12 months. Arrows compare the last 90 days with the 90 before.
MAUDE reports per device
0 →
0 in the last 12 months
Higher volume than 83% of companies with 10+ devices
Recalls per device
0 →
0 in the last 12 months
Higher volume than 97% of companies with 10+ devices
These are reporting-volume percentiles, not safety rankings — MAUDE counts have no denominator of devices in use, and recall attribution follows resolved links. A high percentile means more reports per registered device than peers, which can reflect market size, device criticality, or reporting practice as much as anything else.
Devices
207 device records · ordered by linked event volume.
| Brand | Model | Product codes | Primary DI | Linked events |
|---|---|---|---|---|
| APEX | 9S-005530, 9S-006500 | BTT BZD | 04713025000042 | 1 |
| APEX | 9S-005580 | BZD | 04713025000059 | 1 |
| APEX | 9S-005580, 9S-006500 | BTT BZD | 04713025000066 | 1 |
| APEX | 9S-005530 | BZD | 04713025000035 | 1 |
| APEX | WiZARD 510 | BZD | 04713025001865 | 1 |
| APEX | 9S-005500, 9S-006500 | BTT BZD | 04713025000028 | 1 |
| APEX | 9S-007101 | BZD | 04713025000110 | 1 |
| APEX | 9S-005720 | BZD | 04713025000073 | 1 |
| APEX | 9S-007000 | BZD | 04713025000158 | 1 |
| APEX | WiZARD 510 | BZD | 04713025001872 | 1 |
| APEX | 9S-007100 | BZD | 04713025000141 | 1 |
| APEX | 9S-005500 | BZD | 04713025000011 | 1 |
| APEX | 9S-007200 | BZD | 04713025000134 | 1 |
| APEX | 9S-007001 | BZD | 04713025000127 | 1 |
| APEX | WiZARD 230 | BZD | 04713025000622 | 1 |
| APEX | WiZARD 230 | BZD | 04713025000615 | 1 |
| APEX | 9S-007201 | BZD | 04713025000103 | 1 |
| APEX | 9S-005720, 9S-006500 | BTT BZD | 04713025000080 | 1 |
| Wellell | WiZARD 510 | BZD | 04713025000820 | 1 |
| Wellell | WiZARD 510 | BZD | 04713025000837 | 1 |
| Wellell | WiZARD 520 | BZD | 04719893347272 | 1 |
| Wellell | WiZARD 520 | BZD | 04719893347265 | 1 |
| Wellell | WiZARD 520 | BZD | 04719893347258 | 1 |
| ACS LAL AIR PUMP AND MATTRESS SYSTEM | 0 | |||
| ACS TURN AIR PUMP AND MATTRESS SYSTEM | 0 | |||
| AIR JUNIOR AIR PUMP AND CUSHION SYSTEM | 0 | |||
| APEX | 9P-079000 | FNM | 04719893347791 | 0 |
| APEX | WiZARD 510 | BZD | 04713025000998 | 0 |
| APEX | 9P-079000 | FNM | 04713025004361 | 0 |
| APEX | 9P-087000 | FNM | 04713025004385 | 0 |
Showing 1–30 of 207Next →
Facilities
Registered establishments with their latest FDA inspection outcome.
| FEI | Name | Location | Last inspection | Watch |
|---|---|---|---|---|
| 3006339858 | Apex Medical (Kunshan) Corp. | Kunshan City Jiangsu, CN | NAI | |
| 3004411059 | Wellell Inc. | NEW TAIPEI CITY, TW | VAI |