Neurology · 510(k) · 2024
Oxevision Sleep Device
Oxehealth Limited. Cleared by FDA on 3 April 2024 under submission K233618, product code LEL (device, sleep assessment). What FDA's record says, in FDA's words.
Device record · K233618
- Device. Oxevision Sleep DeviceDEVICE
- Company. Oxehealth Limited (GB)COMPANY
- Decision. 3 April 2024, 510(k), substantially equivalent (traditional review); received 13 November 2023DECISION
- Panel. NeurologyPANEL
- Product code. LEL, Device, Sleep AssessmentCODE
- Regulation. 21 CFR 882.5050, Class IIREG
- Source. FDA database entry · decision document (13 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
The Oxevision Sleep Device is an activity monitor designed and intended for documenting physical movements associated with applications in physiological monitoring. The device's intended use is to analyze subject activity, movement and physiological sign data associated with movement during sleep and to extract information about certain sleep parameters from these movements and physiological sign data. The device provides a timeline of periods when a bed space is occupied, and periods when a subject is asleep when the bed space is occupied. The Oxevision Sleep Device is software assessing video footage from a fixed-installation device for use within single occupancy bed spaces within hospitals, general care and secured environments. The Oxevision Sleep Device is indicated for use on subjects 18 years of age or older.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 13 reports filed against devices carrying product code LEL. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
3 June 2026 · Injury · ACTIGRAPH LEAP · ACTIGRAPH, LLC. · report MW5188877
WE HAVE RECEIVED REPORTS OF LEAP 2.0 DEVICES EXPERIENCING AN INCREASE IN TEMPERATURE, INCLUDING THE THREE MOST RECENT SERIAL NUMBERS PROVIDED (LOT NUMBERS IN PARENTHESES): (B)(6) (0681), (B)(6) (0681), (B)(6) (0651). BASED ON OUR INVESTIGATION, WE DETERMINED THAT THE ELEVATED TEMPERATURE MAY ONLY OCCUR WHEN ALL THE FOLLOWING CONDITIONS ARE TRUE: (A) THE TOUCH SCREEN, TEMPERATURE SENSOR, AND/OR BAROMETER SENSOR WERE ALL ENABLED, (B) THE PLACEMENT OF THE TEMPERATURE SENSOR COMPONENT IS […]
3 June 2026 · Injury · ACTIGRAPH LEAP · ACTIGRAPH L.L.C. · report MW5188878
WE HAVE RECEIVED REPORTS OF LEAP 2.0 DEVICES EXPERIENCING AN INCREASE IN TEMPERATURE, INCLUDING THE THREE MOST RECENT SERIAL NUMBERS PROVIDED (LOT NUMBERS IN PARENTHESES): (B)(6) (0681), (B)(6) (0681), (B)(6) (0651). BASED ON OUR INVESTIGATION, WE DETERMINED THAT THE ELEVATED TEMPERATURE MAY ONLY OCCUR WHEN ALL THE FOLLOWING CONDITIONS ARE TRUE: (A) THE TOUCH SCREEN, TEMPERATURE SENSOR, AND/OR BAROMETER SENSOR WERE ALL ENABLED, (B) THE PLACEMENT OF THE TEMPERATURE SENSOR COMPONENT IS […]
3 June 2026 · Injury · ACTIGRAPH LEAP · ACTIGRAPH L.L.C. · report MW5188879
WE HAVE RECEIVED REPORTS OF LEAP 2.0 DEVICES EXPERIENCING AN INCREASE IN TEMPERATURE, INCLUDING THE THREE MOST RECENT SERIAL NUMBERS PROVIDED (LOT NUMBERS IN PARENTHESES): (B)(6) (0681), (B)(6) (0681), (B)(6) (0651). BASED ON OUR INVESTIGATION, WE DETERMINED THAT THE ELEVATED TEMPERATURE MAY ONLY OCCUR WHEN ALL THE FOLLOWING CONDITIONS ARE TRUE: THE TOUCH SCREEN, TEMPERATURE SENSOR, AND/OR BAROMETER SENSOR WERE ALL ENABLED, THE PLACEMENT OF THE TEMPERATURE SENSOR COMPONENT IS MISALIGNED IN THE […]
28 October 2021 · type not stated · ACTIGRAPH CENTREPOINT INSIGHT WATCH · ACTIGRAPH, LLC · report MW5105016
A CUSTOMER (RESEARCH COORDINATOR) INFORMED ACTIGRAPH THAT A PARTICIPANT REPORTED FEELING A "SHOCK" WHILE WEARING THE WRIST-WORN DEVICE ON (B)(6) 2021. THE PARTICIPANT DESCRIBED WALKING FROM ONE ROOM IN THEIR HOME TO ANOTHER AREA WHEN THEY RECEIVED AN UNEXPLAINED "SHOCK RUNNING FROM THE WRIST TO THE ELBOW." THE PARTICIPANT REMOVED THE DEVICE FOR THE REMAINDER OF THE DAY, BUT THEY CHOSE TO WEAR THE DEVICE THE NEXT DAY. AT THE TIME OF THIS EVENT, THE PARTICIPANT HAD BEEN WEARING THE DEVICE FOR […]
2 March 2018 · Malfunction · DEVILBISS · DEVILBISS HEALTHCARE LLC · report 2515872-2018-00004
AS COMMUNICATED IN AN EMAIL TO DEVILBISS FROM OUR EC REPRESENTATIVE, THE DISTRIBUTOR BASED IN (B)(6) ((B)(4)) ADVISED ABOUT AN EVENT ASSOCIATED WITH A CPAP SLEEPCUBE, MODEL DV54NE-P. THE DISTRIBUTOR COMMUNICATED THE FOLLOWING INFORMATION: "EVENT LOCATION: LIVING ROOM THE PATIENT IN (B)(6). EVENT DESCRIPTION: THE DEVICE WAS CONNECTED TO THE POWER LINE AND THE CUSTOMER LEFT THE ROOM IN WHICH THE DEVICE WAS LOCATED. SHORTLY THEREAFTER, THE SMOKE ALARM SOUNDED AND THE APPLIANCE BURNED ACCORDING TO […]
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code LEL, in Neurology, from Oxehealth Limited, or cleared in 2024. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.