Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart F — Neurological Therapeutic Devices](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices) → [21 CFR 882.5050](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5050) → LEL — Device, Sleep Assessment # LEL · Device, Sleep Assessment _Neurology · 21 CFR 882.5050 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/LEL ## Overview - **Product Code:** LEL - **Device Name:** Device, Sleep Assessment - **Regulation:** [21 CFR 882.5050](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5050) - **Device Class:** 2 - **Review Panel:** [Neurology](/submissions/NE) ## 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](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/LEL/K252981.md) | EmbraceMini | Empatica S.r.l. | Dec 22, 2025 | SESE | | [K251574](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/LEL/K251574.md) | Sleep Watch | Ambulatory Monitoring, Inc. | Jul 31, 2025 | SESE | | [K243513](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/LEL/K243513.md) | DCM (PW-DCM) | Pneumowave, Ltd. | Apr 16, 2025 | SESE | | [K233987](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/LEL/K233987.md) | VERABAND™ | Arbor Medical Innovations, LLC | Jun 17, 2024 | SESE | | [K233618](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/LEL/K233618.md) | Oxevision Sleep Device | Oxehealth Limited | Apr 3, 2024 | SESE | | [K231532](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/LEL/K231532.md) | ActiGraph LEAP activity monitor (ActiGraph LEAP) | Actigraph, LLC | Jun 23, 2023 | SESE | | [K181077](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/LEL/K181077.md) | ActiGraph CentrePoint Insight Watch | Actigraph | May 24, 2018 | SESE | | [K151784](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/LEL/K151784.md) | ActTrust | Condor Instruments Ltda. - Epp | May 25, 2016 | SESE | | [K132764](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/LEL/K132764.md) | MOTION WATCH AND PRO-DIARY | Camntech, Ltd. | Jan 21, 2014 | SESE | | [K111514](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/LEL/K111514.md) | SBV2, MULTICHARGER MODEL MC10V2 | Sleep Performance D.B.A. Fatigue Science | Dec 16, 2011 | SESE | | [K040986](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/LEL/K040986.md) | CADWELL LIMB MOVEMENT MODULE | Cadwell Laboratories, Inc. | Jul 1, 2004 | SESE | | [K040932](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/LEL/K040932.md) | EASYNET BODY POSITION MODULE | Cadwell Laboratories, Inc. | Jul 1, 2004 | SESE | | [K003499](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/LEL/K003499.md) | REMVIEW SLEEP RECORDER, MODEL 320 | Respironics, Inc. | Feb 9, 2001 | SESE | | [K981969](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/LEL/K981969.md) | ULTIMA BODY POSITION SENSOR | Braebon Medical Corp. | Aug 20, 1998 | SESE | | [K961817](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/LEL/K961817.md) | B SMART MODEL 1 | Koven Technology, Inc. | Jul 23, 1997 | SESE | | [K965079](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/LEL/K965079.md) | SOMNITOR 32K SLEEP ACTIVITY MONITOR | Neurim Pharmaceuticals, Ltd. | Jul 10, 1997 | SESE | | [K912817](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/LEL/K912817.md) | SOMNIMIC (R) | Somnitec, Inc. | Jul 26, 1991 | SESE | | [K862766](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/LEL/K862766.md) | EPISON, ALERTING SYSTEM FOR EPILEPTICS | Zygo Industries, Inc. | Mar 13, 1987 | SESE | | [K792305](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/LEL/K792305.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/LEL](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/LEL) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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