Data / Medical devices / Device, Sleep Assessment
Device, Sleep Assessment (LEL): 12 FDA-registered makers in 6 countries
12 establishments in 6 countries are registered with the FDA to make Device, Sleep Assessment (product code LEL, Class 2, 21 CFR 882.5050). 7 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 19 510(k) clearances under this code, the latest on December 22, 2025, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- LEL
- Device class
- 2
- Regulation
- 882.5050
- Medical specialty
- Neurology
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| United Kingdom | 2 |
| Canada | 1 |
| Italy | 1 |
| South Korea | 1 |
| China | 1 |
Makers of Device, Sleep Assessment
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| ActiGraph L.L.C. | Pensacola, FL, United States | Manufacturer, Repackager or relabeler, Specification developer | 2 | June 23, 2023 | 0 | 0 | 0 | api.fda.gov |
| Cadwell Industries, Inc. | Kennewick, WA, United States | Manufacturer | 2 | July 1, 2004 | 0 | 0 | 0 | api.fda.gov |
| Ambulatory Monitoring, Inc. | Ardsley, NY, United States | Specification developer | 1 | July 31, 2025 | 0 | 0 | 0 | api.fda.gov |
| Braebon Medical Corp. | KANATA Ontario, Canada | Manufacturer | 1 | August 20, 1998 | 0 | 0 | 0 | api.fda.gov |
| Camntech | Fenstanton Cambridgeshire, United Kingdom | Manufacturer | 1 | January 21, 2014 | 0 | 0 | 0 | api.fda.gov |
| EMPATICA S.r.l. | Milano, Italy | Complaint file establishment, Manufacturer, Specification developer | 1 | December 22, 2025 | 0 | 0 | 0 | api.fda.gov |
| Oxehealth Ltd | Abingdon Oxfordshire, United Kingdom | Manufacturer | 1 | April 3, 2024 | 0 | 0 | 0 | api.fda.gov |
| Ever Ppe Inc | Sealy, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Happy Health | Austin, TX, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intops Co.,ltd. | Suwon Gyeonggi, South Korea | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Katecho LLC | Des Moines, IA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Fenda Technology Co., Ltd. | Shenzhen Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated December 22, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.