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 | 9P-087000 | FNM | 04713025004385 | 0 |
| APEX | WiZARD 310 | BZD | 04719893347999 | 0 |
| APEX | WiZARD 220 | BZD | 04716872505906 | 0 |
| APEX | 9P-085000 | FNM | 04713025005597 | 0 |
| APEX | Pro-care Optima Prone Pump and Mattress | FMW | 04713025005610 | 0 |
| APEX | 9P-048560 | FNM | 04719893349290 | 0 |
| APEX | 9S-006500 | BTT | 04716872505647 | 0 |
| APEX | SF00001 | BZO | 04716872506873 | 0 |
| APEX | WiZARD 210 | BZD | 04716872506637 | 0 |
| APEX | WiZARD 210 | BZD | 04716872506613 | 0 |
| APEX | 9S-007201 | BZD | 04719893332810 | 0 |
| APEX | WiZARD 220 | BZD | 04713025000721 | 0 |
| APEX | WiZARD 320 | BZD | 04719893334159 | 0 |
| APEX | WiZARD 220 | BZD | 04713025000738 | 0 |
| APEX | WiZARD 310 | BZD | 04713025000769 | 0 |
| APEX | WiZARD 220 | BZD | 04713025000707 | 0 |
| APEX | WiZARD 220 | BZD | 04713025000684 | 0 |
| APEX | WiZARD 320 | BZD | 04719893334173 | 0 |
| APEX | WiZARD 310 | BZD | 04713025000776 | 0 |
| APEX | WiZARD 220 | BZD | 04713025000608 | 0 |
| APEX | WiZARD 220 | BZD | 04713025000592 | 0 |
| APEX | WiZARD 220 | BZD | 04713025000554 | 0 |
| APEX | WiZARD 320 | BZD | 04713025000981 | 0 |
| APEX | WiZARD 310 | BZD | 04719893334258 | 0 |
| APEX | WiZARD 510 | BZD | 04713025000998 | 0 |
| APEX | WiZARD 310 | BZD | 04719893334265 | 0 |
| APEX | 9P-087000 | FNM | 04713025004378 | 0 |
| APEX | 9P-087000 | FNM | 04719893348606 | 0 |
| APEX | 9P-047000 | FNM | 04713025002046 | 0 |
| APEX | 9P-077520 | FNM | 04713025002435 | 0 |
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 |