Device, Sleep Assessment
Regulation 882.5050
1510(k)s in 12 months (19 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in LEL
| Company | 510(k)s | Recalls |
|---|---|---|
| Actigraph | 2 | 0 |
| Cadwell Laboratories, Inc. | 2 | 0 |
| Ambulatory Monitoring, Inc. | 1 | 0 |
| Arbor Medical Innovations, LLC | 1 | 0 |
| Braebon Medical Corp. | 1 | 0 |
| Camntech, Ltd. | 1 | 0 |
| Condor Instruments Ltda. - Epp | 1 | 0 |
| Empatica S.r.l. | 1 | 0 |
| Farrall Instruments, Inc. | 1 | 0 |
| Koven Technology, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 22, 2025 | K252981 | EmbraceMini Empatica S.r.l., IT | LEL |
| Jul 31, 2025 | K251574 | Sleep Watch Ambulatory Monitoring, Inc. | LEL |
| Apr 16, 2025 | K243513 | DCM (PW-DCM) Pneumowave, Ltd., GB | LEL |
| Jun 17, 2024 | K233987 | VERABAND Arbor Medical Innovations, LLC | LEL |
| Apr 3, 2024 | K233618 | Oxevision Sleep Device Oxehealth Limited, GB | LEL |
| Jun 23, 2023 | K231532 | ActiGraph LEAP activity monitor (ActiGraph LEAP) Actigraph, LLC | LEL |
| May 24, 2018 | K181077 | ActiGraph CentrePoint Insight Watch Actigraph | LEL |
| May 25, 2016 | K151784 | ActTrust Condor Instruments Ltda. - Epp, BR | LEL |
| Jan 21, 2014 | K132764 | MOTION WATCH AND PRO-DIARY Camntech, Ltd., GB | LEL |
| Dec 16, 2011 | K111514 | SBV2, MULTICHARGER MODEL MC10V2 Sleep Performance D.B.A. Fatigue Science | LEL |
| Jul 1, 2004 | K040986 | CADWELL LIMB MOVEMENT MODULE Cadwell Laboratories, Inc. | LEL |
| Jul 1, 2004 | K040932 | EASYNET BODY POSITION MODULE Cadwell Laboratories, Inc. | LEL |
| Feb 9, 2001 | K003499 | REMVIEW SLEEP RECORDER, MODEL 320 Respironics, Inc. | LEL |
| Aug 20, 1998 | K981969 | ULTIMA BODY POSITION SENSOR Braebon Medical Corp., CA | LEL |
| Jul 23, 1997 | K961817 | B SMART MODEL 1 Koven Technology, Inc. | LEL |
| Jul 10, 1997 | K965079 | SOMNITOR 32K SLEEP ACTIVITY MONITOR Neurim Pharmaceuticals, Ltd. | LEL |
| Jul 26, 1991 | K912817 | SOMNIMIC (R) Somnitec, Inc. | LEL |
| Mar 13, 1987 | K862766 | EPISON, ALERTING SYSTEM FOR EPILEPTICS Zygo Industries, Inc. | LEL |
| Dec 20, 1979 | K792305 | A SLEEP ASSESSMENT DEVICE Farrall Instruments, Inc. | LEL |
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