LEL — Device, Sleep Assessment Class II
FDA Device Classification
Classification Details
- Product Code
- LEL
- Device Class
- Class II
- Regulation Number
- 882.5050
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K252981 | empatica | EmbraceMini | December 22, 2025 |
| K251574 | ambulatory monitoring | Sleep Watch | July 31, 2025 |
| K243513 | pneumowave | DCM (PW-DCM) | April 16, 2025 |
| K233987 | arbor medical innovations | VERABAND | June 17, 2024 |
| K233618 | oxehealth limited | Oxevision Sleep Device | April 3, 2024 |
| K231532 | actigraph | ActiGraph LEAP activity monitor (ActiGraph LEAP) | June 23, 2023 |
| K181077 | actigraph | ActiGraph CentrePoint Insight Watch | May 24, 2018 |
| K151784 | condor instruments ltda. - epp | ActTrust | May 25, 2016 |
| K132764 | camntech | MOTION WATCH AND PRO-DIARY | January 21, 2014 |
| K111514 | sleep performance d.b.a. fatigue science | SBV2, MULTICHARGER MODEL MC10V2 | December 16, 2011 |
| K040986 | cadwell laboratories | CADWELL LIMB MOVEMENT MODULE | July 1, 2004 |
| K040932 | cadwell laboratories | EASYNET BODY POSITION MODULE | July 1, 2004 |
| K003499 | respironics | REMVIEW SLEEP RECORDER, MODEL 320 | February 9, 2001 |
| K981969 | braebon medical | ULTIMA BODY POSITION SENSOR | August 20, 1998 |
| K961817 | koven technology | B SMART MODEL 1 | July 23, 1997 |
| K965079 | neurim pharmaceuticals | SOMNITOR 32K SLEEP ACTIVITY MONITOR | July 10, 1997 |
| K912817 | somnitec | SOMNIMIC (R) | July 26, 1991 |
| K862766 | zygo industries | EPISON, ALERTING SYSTEM FOR EPILEPTICS | March 13, 1987 |
| K792305 | farrall instruments | A SLEEP ASSESSMENT DEVICE | December 20, 1979 |