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 | "3.5"" Cushion" | FNM | 04713025003845 | 0 |
| APEX | 9S-005720 | BZD | 04719893333091 | 0 |
| APEX | 9P-047000 | FNM | 04713025002046 | 0 |
| APEX | 9P-077520 | FNM | 04713025002435 | 0 |
| APEX | WiZARD 310 | BZD | 04719893334272 | 0 |
| APEX | 9P-079000 | FNM | 04713025002664 | 0 |
| APEX | "8""+2"" Mattress" | FNM | 04713025002725 | 0 |
| APEX | WiZARD 510 | BZD | 04719893347302 | 0 |
| APEX | 9P-079000 | FNM | 04719893347548 | 0 |
| APEX | WiZARD 510 | BZD | 04719893347333 | 0 |
| APEX | 9P-087000 | FNM | 04719893348552 | 0 |
| APEX | 9P-085000 | FNM | 04719893346954 | 0 |
| APEX | SF00001 | BZO | 04716872506873 | 0 |
| APEX | WiZARD 210 | BZD | 04716872506637 | 0 |
| APEX | WiZARD 210 | BZD | 04716872506613 | 0 |
| APEX | WiZARD 210 | BZD | 04716872506606 | 0 |
| APEX | WiZARD 220 | BZD | 04716872505906 | 0 |
| APEX | 9S-007201 | BZD | 04719893332810 | 0 |
| APEX | "Serene with 8""+2"" Mattress" | FNM | 04713025002800 | 0 |
| APEX | WiZARD 310 | BZD | 04719893347982 | 0 |
| APEX | WiZARD 510 | BZD | 04719893347340 | 0 |
| APEX | 9P-047000 | FNM | 04713025003104 | 0 |
| APEX | 9P-087000 | FNM | 04719893348583 | 0 |
| APEX | WiZARD 320 | BZD | 04713025000981 | 0 |
| APEX | WiZARD 310 | BZD | 04713025000776 | 0 |
| APEX | WiZARD 210 | BZD | 04716872506620 | 0 |
| APEX | WiZARD 310 | BZD | 04713025000769 | 0 |
| APEX | WiZARD 320 | BZD | 04719893334173 | 0 |
| APEX | WiZARD 220 | BZD | 04713025000738 | 0 |
| APEX | 9P-079000 | FNM | 04719893347616 | 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 |