| Proprietary Name: | EarWell Ear Correction Splint |
| Classification Name: | SPLINT, EXTREMITY, NON-INFLATABLE, EXTERNAL, NON-STERILE |
| Product Code: | NOC |
| Device Class: | 1 |
| Regulation Number: | 878.3910 |
| Medical Specialty: | General & Plastic Surgery |
| Registered Establishment Name: | BECON MEDICAL Ltd. |
| Registered Establishment Number: | 3006231901 |
| Owner/Operator: | BECON MEDICAL, Ltd. |
| Owner/Operator Number: | 9103543 |
| Establishment Operations: | Specification Developer |