| Proprietary Name: | Zzoma; Zzoma Positional Device; Zzoma Positional Sleeper |
| Classification Name: | PILLOW, CERVICAL (FOR MILD SLEEP APNEA) |
| Product Code: | MYB |
| Device Class: | 2 |
| Regulation Number: | 872.5570 |
| Medical Specialty: | Dental |
| Registered Establishment Name: | Sleep Specialists, LLC |
| Registered Establishment Number: | 3008812550 |
| Premarket Submission Number: | K100160 |
| Owner/Operator: | Sleep Specialists, LLC |
| Owner/Operator Number: | 10034700 |
| Establishment Operations: | Specification Developer |