LEL · Device, Sleep Assessment
Neurology · 21 CFR 882.5050 · Class 2
Overview
| Product Code | LEL |
|---|---|
| Device Name | Device, Sleep Assessment |
| Regulation | 21 CFR 882.5050 |
| Device Class | Class 2 |
| Review Panel | Neurology |
Identification
A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.
Recent Cleared Devices (19 of 19)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252981 | EmbraceMini | Empatica S.r.l. | Dec 22, 2025 | SESE |
| K251574 | Sleep Watch | Ambulatory Monitoring, Inc. | Jul 31, 2025 | SESE |
| K243513 | DCM (PW-DCM) | Pneumowave, Ltd. | Apr 16, 2025 | SESE |
| K233987 | VERABAND | Arbor Medical Innovations, LLC | Jun 17, 2024 | SESE |
| K233618 | Oxevision Sleep Device | Oxehealth Limited | Apr 3, 2024 | SESE |
| K231532 | ActiGraph LEAP activity monitor (ActiGraph LEAP) | Actigraph, LLC | Jun 23, 2023 | SESE |
| K181077 | ActiGraph CentrePoint Insight Watch | Actigraph | May 24, 2018 | SESE |
| K151784 | ActTrust | Condor Instruments Ltda. - Epp | May 25, 2016 | SESE |
| K132764 | MOTION WATCH AND PRO-DIARY | Camntech, Ltd. | Jan 21, 2014 | SESE |
| K111514 | SBV2, MULTICHARGER MODEL MC10V2 | Sleep Performance D.B.A. Fatigue Science | Dec 16, 2011 | SESE |
| K040986 | CADWELL LIMB MOVEMENT MODULE | Cadwell Laboratories, Inc. | Jul 1, 2004 | SESE |
| K040932 | EASYNET BODY POSITION MODULE | Cadwell Laboratories, Inc. | Jul 1, 2004 | SESE |
| K003499 | REMVIEW SLEEP RECORDER, MODEL 320 | Respironics, Inc. | Feb 9, 2001 | SESE |
| K981969 | ULTIMA BODY POSITION SENSOR | Braebon Medical Corp. | Aug 20, 1998 | SESE |
| K961817 | B SMART MODEL 1 | Koven Technology, Inc. | Jul 23, 1997 | SESE |
| K965079 | SOMNITOR 32K SLEEP ACTIVITY MONITOR | Neurim Pharmaceuticals, Ltd. | Jul 10, 1997 | SESE |
| K912817 | SOMNIMIC (R) | Somnitec, Inc. | Jul 26, 1991 | SESE |
| K862766 | EPISON, ALERTING SYSTEM FOR EPILEPTICS | Zygo Industries, Inc. | Mar 13, 1987 | SESE |
| K792305 | A SLEEP ASSESSMENT DEVICE | Farrall Instruments, Inc. | Dec 20, 1979 | SESE |
Top Applicants
- Cadwell Laboratories, Inc. — 2 clearances
- Actigraph — 1 clearance
- Actigraph, LLC — 1 clearance
- Ambulatory Monitoring, Inc. — 1 clearance
- Arbor Medical Innovations, LLC — 1 clearance
