Device, Sleep Assessment
FDA product code LEL · Class II (moderate risk) · 21 CFR 882.5050 · Neurology
19510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Actigraph, LLC 2
- Cadwell Laboratories, Inc. 2
- Sleep Performance D.B.A. Fatigue Science 1
- Empatica S.r.l. 1
- Ambulatory Monitoring, Inc. 1
- Pneumowave, Ltd. 1
- Arbor Medical Innovations, LLC 1
- Oxehealth Limited 1
- Condor Instruments Ltda. - Epp 1
- Camntech, Ltd. 1
- Farrall Instruments, Inc. 1
- Respironics, Inc. 1
- Braebon Medical Corp. 1
- Koven Technology, Inc. 1
- Neurim Pharmaceuticals, Ltd. 1
- Somnitec, Inc. 1
- Zygo Industries, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252981 | EmbraceMiniLEL · Traditional | Empatica S.r.l. | 12/22/2025SE |
| K251574 | Sleep WatchLEL · Special | Ambulatory Monitoring, Inc. | 07/31/2025SE |
| K243513 | DCM (Pw-Dcm)LEL · Traditional | Pneumowave, Ltd. | 04/16/2025SE |
| K233987 | VerabandLEL · Traditional | Arbor Medical Innovations, LLC | 06/17/2024SE |
| K233618 | Oxevision Sleep DeviceLEL · Traditional | Oxehealth Limited | 04/03/2024SE |
| K231532 | ActiGraph LEAP activity monitor (ActiGraph LEAP)LEL · Special | Actigraph, LLC | 06/23/2023SE |
| K181077 | ActiGraph CentrePoint Insight WatchLEL · Special | Actigraph | 05/24/2018SE |
| K151784 | ActTrustLEL · Traditional | Condor Instruments Ltda. - Epp | 05/25/2016SE |
| K132764 | Motion Watch and Pro-DiaryLEL · Traditional | Camntech, Ltd. | 01/21/2014SE |
| K111514 | SBV2, Multicharger Model MC10V2LEL · Traditional | Sleep Performance D.B.A. Fatigue Science | 12/16/2011SE |
| K040986 | Cadwell Limb Movement ModuleLEL · Traditional | Cadwell Laboratories, Inc. | 07/01/2004SE |
| K040932 | Easynet Body Position ModuleLEL · Traditional | Cadwell Laboratories, Inc. | 07/01/2004SE |
| K003499 | Remview Sleep Recorder, Model 320LEL · Abbreviated | Respironics, Inc. | 02/09/2001SE |
| K981969 | Ultima Body Position SensorLEL · Traditional | Braebon Medical Corp. | 08/20/1998SE |
| K961817 | B Smart Model 1LEL · Traditional | Koven Technology, Inc. | 07/23/1997SE |
| K965079 | Somnitor 32K Sleep Activity MonitorLEL · Traditional | Neurim Pharmaceuticals, Ltd. | 07/10/1997SE |
| K912817 | Somnimic (R)LEL · Traditional | Somnitec, Inc. | 07/26/1991SE |
| K862766 | Epison, Alerting System for EpilepticsLEL · Traditional | Zygo Industries, Inc. | 03/13/1987SE |
| K792305 | A Sleep Assessment DeviceLEL · Traditional | Farrall Instruments, Inc. | 12/20/1979SE |